Medication Injection Site and Data Collection System

ABSTRACT

A medication delivery apparatus for use with a medication container includes a housing, a fluid conduit at least partially extending within the housing and configured to deliver medication within the medication container to a patient, a medication port extending from the housing and configured to be coupled to a fluid outlet of the medication container, the medication port being fluidically coupled to the fluid conduit, and at least one sensor disposed within the housing to generate information characterizing administration of the medication for processing by a remote data collection system. The housing can have a size and shape that enables it to be supported by a first hand of a user while the user administers the medication from the medication container via the medication port using a second hand of the user. Related apparatus, systems, and techniques are also described.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/777,831 filed on Feb. 26, 2013, which is a continuation-in-part ofU.S. patent application Ser. No. 12/938,300 filed on Nov. 2, 2010, whichin turn is a continuation-in-part of U.S. patent application Ser. No.12/765,707 filed on Apr. 22, 2010, which in turn is acontinuation-in-part of U.S. patent application Ser. No. 12/614,276filed on Nov. 6, 2009; and additionally, priority is also claimed toU.S. Pat. App. Ser. No. 61/370,974 filed on Aug. 5, 2010. Each of theaforementioned patent applications are entitled: “Medication InjectionSite and Data Collection System”, and are hereby fully incorporated byreference.

FIELD

The subject matter described herein relates to a medication injectionsite for intelligent delivery of medications into a fluid path fordelivery to a patient as well as related data collection and healthcareinformation systems.

BACKGROUND

Many health care procedures involve medication administrations. The typeof medication and timing of administration are important to record inorder to provide healthcare providers real-time information on theconduct of the procedure and the completion of a medical record. Someprotocols require quick medication administrations with limited time fordocumentation and record keeping. Others require completion andverification of medication administration manually to ensure properpatient care and accounting for use of medications. To ensure propersafety, all medication administrations require the administeringclinician to verify the “5 rights” —right patient, right medication,right dose, right time, and right route, which necessitates thecollection, association, and recording of multiple data elements foreach drug given. Additionally, medication administration requirescareful management of injection sites to maintain patency and infectioncontrol.

SUMMARY

In one aspect, a medication delivery apparatus for use with a medicationcontainer is provided. The apparatus can include a housing, a fluidconduit at least partially extending within the housing and configuredto deliver medication within the medication container to a patient, amedication port extending from the housing and configured to be coupledto a fluid outlet of the medication container, the medication port beingfluidically coupled to the fluid conduit, and at least one sensordisposed within the housing to generate information characterizingadministration of the medication for processing by a remote datacollection system. The housing can have a size and shape that enables itto be supported by a first hand of a user while the user administers themedication from the medication container via the medication port using asecond hand of the user.

In another aspect, a medication site is provided that includes ahousing, a junction element, a medication port, one or moreidentification sensors, a transmitter, and a self-contained powersource. The junction element can at least partially extend within thehousing to form a first fluid channel and a second fluid channel. Thefirst fluid channel extends from a first end to a second end. The firstend can be configured to be coupled to a fluid source. The second end ofthe first fluid channel can be configured to form a fluid outlet of themedication injection site to enable coupling to a parenteral fluiddelivery access device (e.g. intravenous, intraosseous, intra-arterial,intramuscular, subcutaneous access device).

The second fluid channel extends from a distal end and terminates at thefirst fluid channel at an intersection intermediate the first end andthe second end. The medication port is fluidically coupled to the distalend of the second fluid channel and is configured to be fluidicallycoupled to a fluid outlet of a medication container. The identificationsensor is disposed within the housing to generate information indicativeof contents of the medication container when the fluid outlet of themedication container is fluidically coupled to the medication port. Thetransmitter is disposed within the housing and in communication with theidentification sensor to wirelessly transmit the information generatedby the identification sensor to a remote data collection system. Theterm transmitter in this context can refer to a transmitter only or atransceiver, a combined transmitter-receiver (unless otherwisespecified). The self-contained power source is disposed within thehousing and it powers components within the medication injection sitesuch as the identification sensor and the transmitter. In someimplementations, the housing has a shape and size enabling it to be heldby a first hand of a user while the user administers medication from themedication container via the medication port using his or her secondhand.

In a further aspect, a medication injection site is provided thatincludes a housing separated from and does not include the first fluidchannel or a junction element. In this implementation, the second fluidchannel becomes the only fluid channel. The housing includes amedication port, an identification sensor, a transmitter and aself-contained power source. The medication port is fluidically coupledto the distal end of the second fluid channel and can be configured tobe fluidically coupled to a fluid outlet of a medication container. Theproximal end of the second channel can be configured to form a fluidoutlet of the medication injection site to enable direct coupling to aparenteral fluid delivery access device (e.g. intravenous, intraosseous,intra-arterial, intramuscular, subcutaneous access device) with littleor no intermediate tubing (e.g., 10 cm or less, etc.). Examples ofdirect coupling can include, but are not limited to, connection to a “Y”site of a tubing set, a patient's catheter, an intraosseous accessdevice or a needle for direct fluid injection.

A largest dimension of the housing can, in some implementations, be lessthan or equal to 10 centimeters. In addition or in the alternative, aweight of the system can be less than or equal to 500 grams, and in someimplementations, less than or equal to 250 grams, and in otherimplementations less than or equal 100 grams. In still furtherimplementations, the weight can be ultra-lightweight and be less than 50grams.

The first end of the first fluid channel can be fluidically coupled totubing extending to a fluid source. The fluid source can be suspended(e.g., IV drip bag, etc.) and fluid contained therein can be gravity fedvia the tubing into the first channel. With such a variation, thehousing can be suspended below the fluid source and supported by thetubing during use. The second end of the first fluid channel can befluidically coupled to a patient. In other variations the housing can belocated downstream more closely associated with the patient's catheter.

A self-contained fluid delivery sensor can be disposed within thehousing and in communication with the transmitter to characterize fluidflow through one or more of the first fluid channel and the second fluidchannel. With such arrangements, the transmitter can wirelessly transmitdata characterizing fluid delivery to the remote data collection system.The fluid delivery sensor can measure fluid flow, volume, medication orfluid type composition and/or pressure in the first fluid channel.Alternatively or in addition, the fluid delivery sensor measures fluidflow, volume, medication or fluid type composition and/or pressure inthe second fluid channel. The fluid delivery sensor can either be apressure sensor, a differential pressure sensor, an optical sensor, anultrasonic sensor, a chemical sensor, a conductivity sensor, amedication composition sensor, a displacement sensor or a fluid flowsensor or a combination of these or other fluid delivery sensors.

In some implementations, a medication composition sensor can be utilizedin order to verify and/or determine the contents of the medicationcontainer. The medication composition sensor can automatically determinethe composition of the medication injected from the medicationcontainer. This can be a sensor or plurality of sensors that determinethe fluid type being injected. This can be compared to the medicationtype indicated by the medication ID Code, if present. The sensor can beany one or more of a pH detector, a viscosity indicator, an opticaldensity indicator, a chemical indicator, a drug molecule indicator, adrug sensor, a spectrophotometer, an HPLC detector, a UV detector, afluid density sensor, a specific gravity fluid sensor, etc.

The junction element can contain a diaphragm portion along one or moreof the first fluid channel and the second fluid channel and the fluiddelivery sensor can be positioned adjacent to the diaphragm.

The remote data collection system can calculate volume of fluiddelivered via the medication port based on the wireless transmitted datacharacterizing fluid delivery. Alternately, or in addition, the volumeof fluid delivered can be calculated locally within the medication porthousing and such volume data can be transmitted wirelessly to the remotedata collection system.

A self-contained power source can be disposed within the housing topower one or more of the identification sensor, the fluid deliverysensor, and the transmitter.

An intersection of the first fluid channel and the second fluid channelcan form a substantially T-shaped junction. In other variations, anintersection of the first fluid channel and the second fluid channel canform a substantially Y-shaped junction.

The medication port can define a cavity extending inwardly from an outersurface of the housing such that the fluid outlet of the medicationcontainer is substantially enveloped within the housing and does notextend beyond the outer surface when such fluid outlet is mechanicallycoupled to the port. The medication port can be a needleless injectionport or a one-way port valve.

The medication container can bear an information source characterizingthe medication container and/or its contents. The information source canbe, for example, mechanically encoded information, magnetically encodedinformation, and radio frequency readable information. The informationsource can also or alternatively comprise optically encoded informationand the identification sensor can comprise an optical emitter and anoptical detector to read the optically encoded information. Theidentification sensor can include an optical emitter LED to illuminatethe information source and an optical detector such as a camera (chargecoupled device—CCD). The identification sensor can read information fromthe information source as a result of relative motion of the fluidoutlet of the medication container relative to the medication port. Theidentification sensor can read information from the information sourcein response to mechanically coupling the fluid outlet to the medicationport.

The medication container can be a needle-less syringe, and the fluidoutlet can be a tip of the syringe. The medication container can be avial and the fluid outlet can be the stopper at the vial closure. Themedication container can be a premixed solution provided in a bag, andthe fluid outlet can be a luer fitting connector or an IV set spikeableport. The medication container can be a small disposable, rigid,semi-rigid or flexible envelope that contains medication foradministration to a patient and the fluid outlet can be an integral luerfitting on the container, at the end of tubing attached to the containeror part of a fluid transfer device used with medication vials. Themedication container can be a fluid delivery tubing set and the fluidoutlet can be an integral luer fitting at the end of tubing attached tothe container.

The junction element can be a unitary injection molded fitting.

Medication can be intermittently delivered through the medication portsuch that it is continuously or substantially continuously delivered tothe first fluid channel via the first end of the first fluid channel.Alternately, medication can be intermittently delivered through themedication port such that it is only delivered to the second fluidchannel.

A first check valve can be disposed within the first fluid channelintermediate the intersection and the first end of the first fluidchannel to prevent fluid delivered into the medication port from exitingthe first fluid channel at the first end. A second check valve can bedisposed within the secondary fluid channel to prevent fluid enteringthe first fluid channel at the first end from exiting the secondaryfluid channel at the distal end. The second check valve can be theneedleless injection port or a one-way port valve.

The housing can comprise a plurality of sections, and one or more of thefirst fluid channel and the second channel can be formed when at leasttwo of the sections are assembled. At least two of the sections of thehousing can be injection molded and one or more of the first fluidchannel and the second fluid channel can be formed by one or moreinjection molded sections.

In one implementation, the medication injection site can be separatedinto two sub-housings, a reusable sub-housing, a disposable sub-housingthat are coupled to each other via a connection interface. The reusablesub-housing can be used by one or more patients while the disposablesub-housing is intended to only be used by a single patient (i.e., thecomponents contained within the disposable sub-housing provide a sterilefluid passageway which are separate from the components within thereusable sub-housing ensuring patient safety). The reusable sub-housingcan contain elements of the medication injection site that are not partthe first fluid channel or the second fluid channel (e.g., one or moreof the identification sensor(s), the fluid delivery sensor, thetransmitter, a processor, a memory, etc.). The disposable sub-housingcan contain one or both of the first fluid channel and the second fluidchannel. The power source can be positioned in either sub-housing.

A removable sterility cap can be affixed to the medication port. Removalof the sterility cap can initiate communications between the transmitterand the remote data collection system.

A self-contained power source (e.g., battery, battery array, etc.) canbe disposed within the housing powering one or more of theidentification sensors, the fluid delivery sensor, and the transmitter.Removal of the sterility cap affixed to the medication port can initiateprovision of electricity by the power source to the identificationsensors and the transmitter.

The shape and size of the housing can enable positioning of the housingon the arm or leg of a patient adjacent to an injection site on thepatient, positioned on a “Y” site of fluid delivery tubing set,connected directly to a patient catheter or attached to a needle fordirect injection. The shape and size of the housing can enablepositioning of the housing on a patient at or near a peripheral venousaccess site, a central venous line, a subcutaneous access site, anintra-muscular access site, or an intraosseous access device.

The medication port, can in some variations, be disposed wholly or atleast substantially wholly within the housing. The medication port canadditionally or alternatively be integrated into the junction element.

A memory element can be disposed within the housing that can storeinformation obtained from the identification sensors and/or the fluiddelivery sensor. A timing element can be coupled to the memory elementto enable recordation of events corresponding to what medication isadministered, the time of medication administration, what volume ofmedication was administered, the duration of medication administration,identification sensor information from a second information source andthe time of wireless transmission of information generated by theidentification sensors. The remote data collection system can wirelesslyrequest the transmitter to send information stored in the memory elementobtained from the sensors. In addition, the remote data collectionsystem can comprise a timing element to assign clock times to each datarecord based on absolute time and duration between recordedtransmissions.

The system can include an identifier (e.g., serial number oralphanumeric identifier, bar code label, etc.) to uniquely identifywireless transmissions from the transmitter. The identifier can beencapsulated in some or all of the wireless transmissions, or it can bemanually accessed or scanned by a practitioner.

The medication injection site can be enveloped in a sterile pouch (i.e.,enclosure, etc.). The medication injection site can be part of a kitthat also contains instructions for use.

In a first interrelated aspect, a medication injection site includes ahousing, a junction element, a medication port, one or moreidentification sensors, a transmitter, and a self-container powersource. The junction element at least partially extends within thehousing forming a first fluid channel and a second fluid channel. Thefirst fluid channel extends from a first end to a second end. The secondfluid channel extends from a distal end and terminates at the firstfluid channel at an intersection intermediate the first end and thesecond end. The medication port is fluidically coupled to the distal endof the second fluid channel and is can be configured to be fluidicallycoupled to a fluid outlet of a medication container. One identificationsensor can be disposed adjacent to the second fluid channel to generateinformation indicative of contents of the medication container when thefluid outlet of the medication container is fluidically coupled to themedication port. A second identification sensor can be disposed withinthe housing to generate information complementary to the medicationcontainer information (e.g., information about the patient, about themedication procedure, the medication and/or its preparation, thecaregiver administering the medication, etc.). The transmitter isdisposed within the housing and in communication with the identificationsensors to wirelessly transmit the information generated by theidentification sensors to a remote data collection system. Aself-contained power source is disposed within the housing powering theidentification sensors and the transmitter.

Activation of the second identification sensor can be manual (usermanipulation, etc.) or automated (apparatus is activated remotely,etc.). Activation can be through mechanical, electronic, optical,magnetic or remote communication means.

A self-contained fluid delivery sensor can be disposed within thehousing and in communication with the transmitter to characterize fluidflow through one or more of the first fluid channel and the second fluidchannel. With such a variation, the transmitter further can wirelesslytransmit data characterizing fluid delivery to the remote datacollection system.

In yet another interrelated aspect, a medication injection site includesa housing, a medication port extending from an outer surface of thehousing, an identification sensor disposed within the housing togenerate information indicative of contents of the medication containerwhen the fluid outlet of the medication container is fluidically coupledto the medication port, an identification sensor disposed within thehousing to generate information complementary to the contents of themedication container when the sensor is proximal to the complementaryinformation source, a transmitter disposed within the housing and incommunication with the identification sensors to wirelessly transmit theinformation generated by the identification sensors to a remote datacollection system. The housing has a shape and size enabling it to beheld by a first hand of a user while the user administers medicationfrom the medication container via the medication port using his or hersecond hand.

In a further interrelated aspect, an apparatus to identify contents of amedication container is provided. Such a medication container includes abarrel portion, a fluid outlet tip, and a tapered portion intermediatethe barrel portion and the fluid outlet tip. The apparatus includes anidentification member having an opening larger than a diameter of thefluid outlet tip and smaller than or equal to the diameter of the barrelportion. In other variations the identification member can be slightlylarger in diameter than the barrel portion. The identification membercan contain optical, magnetic, and/or mechanically encoded information.The information can be indicative of one or more of the contents of themedication container, the volume of fluid within the medicationcontainer, and the expiration date of the contents of the medicationcontainer. Additionally, information on the identification member caninclude a unique identifier (such as a serial number, random IDidentifier {alpha-numeric sequence, hexadecimal code with-or-without aprefix, suffix, code base subscript number} or other unique informationdata, prefix, suffix, symbol or color, etc.). This information can beused to identify the container and provide for tracking it through themedication usage cycle. The information can be patient specific orpatient neutral.

The information can be readable by an identification sensor when theidentification member is located around the fluid outlet tip and theapparatus is coupled to or adjacent to a fluid delivery system todeliver contents of the medication container.

In a further interrelated aspect, an apparatus (e.g., a complementarydata sensor, etc.) to identify information complementary to themedication container can be provided (either integrated into themedication injection site or used in conjunction with same). Theapparatus can include a second identification member and identificationsensor. The second identification member can contain optical (1dimensional barcode, 2 dimensional barcode, symbol, image or picture),magnetic (magnetic strip on an identification card/badge/ID tag), a NearField Communication (NFC) tag, RFID, and/or mechanically encodedinformation. The information can be indicative of one or more of thefollowing: a patient (patient ID, weight, height, sex, age, pre-existingmedical conditions, current medical state, Broselow color); a patientsample (sample ID, blood sample, urine sample, tissue sample, stoolsample, other body fluid sample, etc.); a medical device (device ID, IVpump, EKG monitor, defibrillator, pulse oximeter, blood pressuremonitor, etc.); a caregiver (picture, ID, name, affiliation, etc); apharmacy record (prescription, patient ID, medication formulation,preparation date, expiration date, administration instructions and orprecautions, pharmacy ID, preparer ID, etc.).

This information can be used to associate treatment information with amedication injection and with its use on a particular patient. Theinformation can be readable by an identification sensor when theidentification member is located proximal to the identification sensoror is coupled to or adjacent to the apparatus.

In a further aspect, a medication injection site is provided thatincludes a housing separated from the first fluid channel. In thisvariation, the second fluid channel becomes the only fluid channel. Themedication port is fluidically coupled to the distal end of the secondfluid channel and can be configured to be fluidically coupled to a fluidoutlet of a medication container. The proximal end of the second channelcan be configured to form a fluid outlet of the medication injectionsite to enable direct coupling to a parenteral fluid delivery accessdevice. An identification sensor is disposed adjacent to the secondfluid channel to generate information indicative of contents of themedication container when the fluid outlet of the medication containeris fluidically coupled to the medication port. A second identificationsensor (sometimes referred to as a complementary data sensor, etc.) canbe disposed within the housing to generate information complementary tothe contents of the medication container when the sensor is proximal tothe complementary information source. The transmitter is disposed withinthe housing and in communication with the identification sensors towirelessly transmit the information generated by the identificationsensors to a remote data collection system. Additionally, a fluiddelivery sensor can be disposed within the housing and in communicationwith the transmitter to wirelessly transmit the information generated bya fluid flow/volume sensor to a remote data collection system. Aself-contained power source can be disposed within the housing poweringthe identification sensors, fluid delivery sensor and the transmitter.

In yet another aspect, a housing can include a reusable sub-housing anda disposable sub-housing. The reusable sub-housing can be operativelycoupled to the disposable sub-housing. In addition, the reusablesub-housing is intended for use by a plurality of patients and thedisposable sub-housing is intended for use by a single patient. Such anarrangement can also include a medication port configured to befluidically coupled to a fluid outlet of a medication container, anidentification sensor disposed within the housing to generateinformation indicative of contents of the medication container when thefluid outlet of the medication container is fluidically coupled to themedication port, a transmitter disposed within the housing and incommunication with the identification sensor to wirelessly transmit theinformation generated by the identification sensor to a remote datacollection system, and a power source disposed within the housingpowering the identification sensors and the transmitter.

In one implementation, the medication port is within the disposablesub-housing and one or more of the identification sensors, thetransmitter, and the power source are in the reusable sub-housing.

The identification member can be disposed radially about a central fluidoutlet axis of the fluid outlet tip enabling detection of theinformation when the medication container is rotated about the centralfluid outlet axis.

The information can be disposed linearly enabling detection of theinformation when the medication container is joined with a fluid pathwayalong a central fluid outlet axis of the medication container. Theinformation can be selected from a group comprising: optically encodedinformation, magnetically encoded information, radio frequencydetectable information, and mechanically detectable information.

The medication container can be a first medication container and theidentification member can be releasably secured to the medicationcontainer to allow it to be removed for placement on a second medicationcontainer. The identification member can bear an attachment elementallowing it to be removed from the first medication container andaffixed to the second medication container. Transfer of theidentification member from the first medication container to the secondmedication container can be completed during the process of transferringthe medication from the first medication container to the secondmedication container.

The identification member can be a label or other element adhered to,printed on, and/or etched onto the medication container. Theidentification member can be integral to the medication container. Theidentification member can be a ring shaped member configured to fitaround the fluid outlet tip. The identification member can be a disk orcup shaped member configured to fit over the fluid outlet tip.

In another aspect, a system can include a housing, a medication port, atransmitter, and a power source. The medication port is configured to befluidically coupled to a fluid outlet of a medication container. Theidentification sensor generates information indicative of contents ofthe medication container when the fluid outlet of the medicationcontainer is fluidically coupled to the medication port. The transmitteris in communication with the identification sensor to wirelesslytransmit the information generated by the identification sensor to aremote data collection system. The remote data collection system can becoupled to or integral with a secondary medical device. The power sourcecan power the identification sensor and the transmitter.

The secondary medical device can be, for example, a physiologicalsensor, a defibrillator, an infusion pump, a ventilator, an anesthesiamachine.

Example physiological sensors include an EKG monitor, an EEG monitor, ablood pressure monitor, an ETCO2 monitor, and/or a pulse oximeter. Theremote data collection system can also comprise a bar code medicationadministration (BCMA) system.

The data collection system can receive information from one or moremedication injection sites and/or one or more secondary medical devices.The data collection system can be coupled to or form part of a cellularphone or other mobile computing system (e.g., tablet computer, IPAD,etc.). The data collection system can provide collected data to othersystems (medical information systems, emergency medical services (EMS)information systems, hospital information systems, remote monitoringsystems, event management systems, home health care monitoring systems,medication waste disposal management systems, telemedicine systems,etc.) and or receive information from other systems (hospitalinformation systems, remote systems, event management systems, homehealth care monitoring systems, medication waste disposal managementsystems, telemedicine systems, etc.). The data collection system caninclude a set of rules with alerts and alarms to provide healthcareproviders with information regarding the medications injected, to beinjected or which need to be disposed/wasted.

Still further, in some implementations the housing can comprise at leastone fluid characterization sensor. Such at least one fluidcharacterization sensor can be used to characterize the contents of themedication container and/or administration of the contents of themedication container. The at least one fluid characterization sensor cancomprise, for example, an identification sensor and/or a fluidcharacterization sensor.

In yet a further aspect, a method is provided in which information isreceived (e.g., by at least one data processor, etc.) from a medicationdelivery apparatus as described herein that characterizes administrationof medication to a patient. Thereafter, the information is associated(e.g., by at least one data processor, etc.) with data specifying atleast one medication and/or a volume of medication. Once thisassociation has been performed, the associated data is promoted (e.g.,display, store, transport, etc.).

In a further interrelated aspect, a system includes a housing, amedication port, a first identification sensor, a second sensor (whichmay be a second identification sensor), and a transmitter. Themedication port extends from an external face of the housing and isconfigured to be fluidically and directly coupled to a fluid outlet of amanually injectable medication container comprising medication foradministration to a patient. The first identification sensor is disposedwithin the housing and generates identification information indicativeof contents of the medication container when the fluid outlet of themedication container is fluidically coupled or is being fluidicallycoupled to the medication port. The second sensor is disposed within thehousing and detects information on a source other than the medicationcontainer that is associated with the administration of the contents ofthe medication container. The transmitter is disposed within the housingand is in communication with the first identification sensor and thesecond sensor to wirelessly transmit the information generated by thefirst identification sensor and the second sensor to a remote datacollection system.

One or more of the first identification sensor and the second sensor caninclude a near field communication (NFC) sensor or a proximity sensor.

The second sensor can further detect information on the medicationcontainer that is associated with the administration of the contents ofthe medication container.

The information detected by the first identification sensor and/or thesecond sensor can comprise one or more of: a one dimensional barcode, atwo dimensional barcode, symbolic information, an image, magnetic media,a near field communication (NFC) tag, biometric data, RFID encodedinformation.

The information detected by the first identification sensor and/orsecond sensor can characterize one or more of the patient, demographicsassociated with the patient, a medical record for the patient, a pictureof the patient, a video associated with the patient, a biometric patientidentifier (ID), a medical record number, physical characteristics ofthe patient, allergies of the patient, contraindications, and BROSELOWcolor.

The information detected by the second sensor can characterize one ormore of a patient sample such as a blood sample, a urine sample, atissue sample, a stool sample, and the like.

The information detected by the second sensor can characterize a medicaldevice such as an intravenous (IV) pump, an EKG monitor, adefibrillator, a pulse oximeter, and a blood pressure monitor.

The information detected by the second sensor can characterize fluids,medications, and food provided to the patient.

The information detected by the second sensor can characterize bodilywaste of the patient.

The information detected by the second sensor can characterizes adiagnostic test or treatment result for the patient such as lab values,radiological images, radiological reports, vital sign trends, EKG strip,and clinical reports.

The information detected by the second sensor can characterize acaregiver associated with the patient. The information cancharacterizing the caregiver associated with the patient can be, forexample, a picture of the caregiver, a video of the caregiver, anidentification code associated with the caregiver, a password associatedwith the caregiver, an identification of the caregiver, a name of thecaregiver, an affiliation of the caregiver, a responsible clinicianassociated with the caregiver, a decision-making authority associatedwith the caregiver.

The information detected by the second sensor can characterize one ormore of a person accompanying the patient, a relationship of the personto patient, a companion, a picture of the person, a fingerprint of theperson, an affiliation of the patient, a religion of the patient,contact information for the patient, breast milk information associatedwith the patient, organ donation information for the patient, medicaldirectives associated with the patient, and caregiving instructionsassociated with the patient.

The information detected by the second sensor can characterize apharmacy record such as prescription number, patient identifier,formulation, expiration date, administration instructions, precautionsinstructions, contraindications, medication reconciliation information,pharmacy identifier, and preparer identifier.

The information detected by the second sensor can characterize aphysician's order such as medication administrations orders, lab orders,diagnostic testing orders, radiological orders, treatment orders, andtherapy orders.

The information detected by the second sensor can characterize anenvironmental factor associated with the patient such as a room numberfor the patient, a temperature of the room for the patient, a time, acare transition status, a time of admission of the patient, and a timeof last bed sheet change for the patient.

The information detected by the second sensor can characterize one ormore of: medication type, medication concentration, medicationexpiration date, medication NDC, and RxNorm code.

The medication container can be one or more of syringes, vials, fluidbags, ampoules, blood bags, IV tubing sets, medication patches, andauto-injection devices.

The source detected by the second sensor can be one or more of a patientwrist band, an oral solid package, a patient sample container, and amedical device.

The remote data collection system can form part of a barcode medicationadministration (BCMA) system.

In a further aspect, a system can include a housing, a medication port,a first sensor, a second sensor, and a transmitter. The medication portcan extend from an external face of the housing and is configured to befluidically and directly coupled to a fluid outlet of one of a pluralityof manually injectable medication containers. The manually injectablemedication containers can have identification information on one or moreof a first portion and a second portion and comprising medication foradministration to a patient. The first sensor can be disposed within thehousing to generate data derived from the identification information ona first portion of a medication container coupled to the medication port(if the medication container has information on the first portion). Thesecond sensor can be disposed within the housing to generate dataderived from the identification information on a second portion of amedication container coupled to the medication port (if the medicationcontainer has information on the second portion). The transmitter can bedisposed within the housing and can be communication with the firstsensor and the second sensor to wirelessly transmit data generated bythe first sensor and the second sensor to a remote data collectionsystem. In some variations, the first sensor can generate the data whenthe fluid outlet of the medication container is fluidically coupled oris being fluidically coupled to the medication port.

In a further interrelated aspect, an apparatus includes a housing, afluid port, an identification sensor, and a transmitter. The fluid portcan extend from an outer surface of the housing and is configured to becoupled to a fluid outlet of a fluid container (that can contain avariety of fluids including, for example, medication). Theidentification sensor can be disposed within the housing to generateinformation indicative of contents of the fluid container when the fluidoutlet of the medication container is fluidically coupled to the fluidport. The transmitter can be disposed within the housing and can be incommunication with the identification sensor to wirelessly transmit theinformation generated by the identification sensor to a remote datacollection system. In some variations, the housing can have a shape andsize enabling it to be held by a first hand of a user while the useradministers fluid from the fluid container via the fluid port using hisor her second hand.

In one variation, a method can be implemented by an apparatus thatincludes a housing, a medication port extending from an external face ofthe housing configured to be fluidically and directly coupled to a fluidoutlet of a manually injectable medication container comprisingmedication for administration to a patient, a first identificationsensor disposed within the housing to generate identificationinformation indicative of contents of the medication container when thefluid outlet of the medication container is fluidically coupled or isbeing fluidically coupled to the medication port, a second sensordisposed within the housing to detect information on a source other thanthe medication container that can be associated with the administrationof the contents of the medication container, and a transmitter disposedwithin the housing and in communication with the first identificationsensor and the second sensor to wirelessly transmit the informationgenerated by the first identification sensor and the second sensor to aremote data collection system. The method can include generating data bythe first identification sensor indicative of contents of the medicationcontainer when the fluid outlet of the medication container isfluidically coupled or is being fluidically coupled to the medicationport, generating data by the second sensor associated with theadministration of the contents of the medication container, andtransmitting the data generated by the first identification sensor andthe second sensor to the remote data collection system.

In a further aspect, a method can be provided that is implemented by oneor more data processors that includes receiving, by at least one dataprocessor, information from a medication delivery apparatuscharacterizing administration of medication to a patient, associating,by at least one data processor, the information with data specifying atleast one medication and/or a volume of medication, and promoting theassociated data. The medication delivery apparatus can include ahousing, a medication port extending from an external face of thehousing configured to be fluidically and directly coupled to a fluidoutlet of a manually injectable medication container comprisingmedication for administration to a patient, a first identificationsensor disposed within the housing to generate identificationinformation indicative of contents of the medication container when thefluid outlet of the medication container is fluidically coupled or isbeing fluidically coupled to the medication port, a second sensordisposed within the housing to detect information on a source other thanthe medication container that is associated with the administration ofthe contents of the medication container, and a transmitter disposedwithin the housing and in communication with the first identificationsensor and the second sensor to wirelessly transmit the informationgenerated by the first identification sensor and the second sensor to aremote data collection system.

In a further aspect, a system can include a housing, a medication port,a first identification sensor, a second identification sensor, and atransmitter. The medication port can extend from an external face of thehousing and can be configured to be fluidically and directly coupled toa fluid outlet of a manually administrable medication containercomprising medication for administration to a patient. The firstidentification sensor can be disposed within the housing to generateidentification information indicative of the contents of a medicationcontainer when the fluid outlet of the medication container isfluidically coupled or is being fluidically coupled to the medicationport. The second identification sensor can be disposed within thehousing to detect information indicative of the contents of a medicationcontainer intended for administration to a patient when the medicationcontainer is in contact with or proximate to the sensor. The transmittercan be disposed within the housing and can be in communication with thefirst identification sensor and the second identification sensor towirelessly transmit the information generated by the firstidentification sensor or the second identification sensor to a remotedata collection system.

The first identification sensor or the second identification sensor cangenerate information indicative of the contents of a fluid medication tobe administered to the patient through the medication port.

The second identification sensor can generate information indicative ofthe contents of a medication container to be administered to the patientthrough a route other than the medication port.

The medication can be an IV fluid, a subcutaneous fluid, anintramuscular fluid, an oral solid, an oral liquid, a topicalpreparation, a transdermal patch, or a suppository.

In still a further interrelated aspect, a medication delivery apparatusfor use with a medication source is provided that includes a housing, afluid conduit, a medication port, and at least one first sensor. Thefluid conduit can at least partially extend from the housing and can beconfigured to deliver medication from the medication source to a patientvia a parenteral fluid administration pathway. The medication port canextend from an external surface of the housing and can be configured tobe coupled to a tubing set coupled to the medication source. Inaddition, the medication port can be fluidically and directly coupled tothe fluid conduit. The at least one first sensor can be disposed withinthe housing to generate information characterizing administration of themedication for processing by a remote data collection system.

The medication delivery apparatus can include at least one second sensordisposed within the housing to generate complementary information forprocessing by the remote data collection system. The complementaryinformation can comprise encoded information. The remote data collectionsystem can associate the information generated by the at least onesensor and/or the complementary information generated by the at leastone second sensor with one or more of: medication information, patientidentification, patient weight, patient sex, patient age, patientBROSELOW color, pre-existing and/or current patient medical conditions,patient sample, medical device being used by the patient, caregivername, caregiver photograph, caregiver ID, caregiver employer, a pharmacyrecord, pharmacy administration instructions, physicians orders.

Tubing between the fluid conduit and a parenteral access device can, forexample, be 10 cm or less.

The medication delivery apparatus can include a transmitter within thehousing to transmit information generated by the at least one sensor tothe remote data collection system; and a self-contained power sourcewithin the housing powering the at least one first sensor and thetransmitter. The remote data collection system can receive informationwirelessly from the transmitter.

The housing comprises a reusable sub-housing and a disposablesub-housing, the disposable sub-housing being used by a single patientand including at least the fluid conduit and the medication port, thereusable sub-housing being used by a plurality of patients and includingthe at least one first sensor. The re-usable sub-housing can beoperatively coupled to the disposable sub-housing by a connectioninterface including one or more of an electrical contact, an RFcoupling, an optical coupling, a hydraulic coupling, a mechanicalcoupling, and a magnetic coupling.

The fluid conduit can include a first fluid channel and a second fluidchannel with the first fluid channel extending from a first end to asecond end and the second fluid channel extending from a distal end andterminating at the first fluid channel at an intersection intermediatethe first end and the second end.

The medication delivery apparatus can be integral to and/or configuredto be suspended below a fluid source.

The at least one first sensor can include an identification sensor andthe tubing set includes an information source such that theidentification sensor reads the information from the information source.The information source can be disposed proximate to a fitting of thetubing set. The information source can be disposed upon a cylindrical orannular surface that is concentric to the fluid outlet of the tubing setand the sensor can generate the information characterizingadministration of the medication when the tubing set is coupled and/orbeing coupled to the medication port.

The at least one first sensor can include a fluid flow sensor and theinformation can include information indicative of an amount of fluiddelivered from the medication source to the patient.

The at least one first sensor can include a medication composition typesensor such that the information includes information characterizing thecomposition of the medication.

The remote data collection system can receive, transmit, integrateand/or report information from and/or to a medical information sourceselected from a group comprising: a medical device, and a medicalinformation system.

The remote data collection system can provide real-time information to auser including, for example, medication information, medical dataspecific to a patient, procedural instructions and/or protocols forpatient treatment.

The remote data collection system can provide a rule set definingconditions to alert and/or guide a caregiver using the apparatus.

A memory element can be disposed within the housing for storinginformation generated by the at least one first sensor.

An indicator element can be disposed within the housing for indicatingthe operational state of the medication delivery apparatus and/orilluminating the medication port providing user information.

The at least one first sensor can be one or more of a flow volumesensor, a flow rate measurement sensor, a composition sensor, a pressuresensor, an air in line sensor, and a temperature sensor.

The medication delivery apparatus can be included in a kit comprising asterile pouch. The medication delivery apparatus can be provided withinthe pouch in a sterile condition.

In another variation, a medication delivery apparatus for use with amedication source can include a housing, a fluid conduit, a medicationport, at least one sensor, a transmitter, and a self-contained powersource. The fluid conduit can at least partially extend from the housingand be configured to deliver medication within the medication source toa patient. The medication port can extending from an external surface ofthe housing and be configured to be coupled to a fluid outlet of atubing set coupled to the medication source. The medication port can befluidically and directly coupled to the fluid conduit. The at least onesensor can be disposed within the housing to generate informationcharacterizing administration of the medication. The transmitter can bedisposed within the housing to wirelessly transmit information generatedby the sensor to a remote data collection system. The self-containedpower source can be disposed within the housing to power the at leastone sensor and the transmitter.

In yet a further variation, a method can include receiving, by at leastone data processor, information from a medication delivery apparatuscharacterizing administration of medication to a patient, associating,by at least one data processor, the information with data specifying atleast one medication and/or a volume of medication, and promoting theassociated data. The medication delivery apparatus can include ahousing, a fluid conduit at least partially extending within the housingand configured to deliver medication from the medication source to apatient via a parenteral fluid administration pathway, a medication portextending from an external surface of the housing and configured to becoupled to a tubing set coupled to the medication source, the medicationport being fluidically and directly coupled to the fluid conduit, and atleast one first sensor disposed within the housing to generateinformation characterizing administration of the medication forprocessing by a remote data collection system. Promoting the associateddata can include persisting the associated data, loading the associateddata, presenting the associated data in a display device, and/ortransmitting the associated data to a remote computing system.

Computer program products are also described that comprisenon-transitory computer readable media storing instructions, which whenexecuted one or more data processor of one or more computing systems,causes at least one data processor to perform operations herein.Similarly, computer systems are also described that may include one ormore data processors and a memory coupled to the one or more dataprocessors. The memory may temporarily or permanently store instructionsthat cause at least one processor to perform one or more of theoperations described herein. In addition, methods can be implemented byone or more data processors either within a single computing system ordistributed among two or more computing systems. Such computing systemscan be connected and can exchange data and/or commands or otherinstructions or the like via one or more connections, including but notlimited to a connection over a network (e.g. the Internet, a wirelesswide area network, a local area network, a wide area network, a wirednetwork, or the like), via a direct connection between one or more ofthe multiple computing systems, etc.

The subject matter described herein provides many advantages. Forexample, the current subject matter allows for compact fluid injectionport systems that automatically identify administered medication and/ordetermine volume and/or type of administered medication. The fluidinjection port is sufficiently small to be placed on a standard IV line(and to be self-supporting) allowing it to be used in multiplesituations including on-site paramedic treatments, during ambulancedelivery of patients, as well as medical facilities such as emergencyrooms/intensive care units/operating rooms/general care. Moreover, asmedical staff (e.g., doctors, nurses, paramedics, etc.) are accustomedto delivering medicine through Y-sites on IV lines, through cathetersand needles, the current subject matter requires little, if any,behavior modifications while allowing for intelligent delivery ofmedication and logging of administered medications. In addition, thecompact nature of the fluid injection port obviates the need for alarger tabletop or cradle unit which can be cumbersome during code blueor other emergency events and which can require much needed space(displacing other required equipment). In addition, the current subjectmatter utilizes a wireless interface and does not require wires forcommunication of information to a data collection system which couldinterfere with or complicate patient care activity. In addition, datareceived by the data collection system can be actively displayed inreal-time providing clearly visible information to the medical staffkeeping all informed and up-to-date. Furthermore, the current subjectmatter eliminates manual record keeping and other activities that cantend to detract from the needed attention to a patient. Automated recordkeeping provides accurate records and frees up the health careprovider's time enabling improved patient care. Lastly, the currentsubject matter is advantageous in that the medication injection site canbe disposable (thereby increasing patient safety).

The details of one or more variations of the subject matter describedherein are set forth in the accompanying drawings and the descriptionbelow. Other features and advantages of the subject matter describedherein will be apparent from the description and drawings, and from theclaims.

DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, show certain aspects of the subject matterdisclosed herein and, together with the description, help explain someof the principles associated with the disclosed embodiments. In thedrawings:

FIG. 1 is a diagram illustrating a healthcare provider using amedication injection site in connection with the care of a patient;

FIG. 2A is a diagram illustrating a first variation of a medicationinjection site with a medication port flush with or disposed within acavity of a housing;

FIG. 2B is a diagram illustrating a second variation of a medicationinjection site with a medication port extending outside a housing;

FIG. 2C is a diagram illustrating a third variation of a medicationinjection site with a medication port directly connected to a fluiddelivery tubing set “Y” site;

FIG. 2D is a diagram illustrating a fourth variation of a medicationinjection site with a medication port directly connected to a needle;

FIG. 3A is diagram illustrating a detailed view of a medicationinjection site as in FIG. 2A;

FIG. 3B is a diagram illustrating a side view of a medication injectionsite as in FIG. 3A;

FIG. 3C is a diagram illustrating a magnified cross-sectional view ofelements in FIG. 3B;

FIG. 4A is a diagram illustrating a medication injection site with amedication container bearing an alternate information source to that ofFIG. 3A;

FIG. 4B is a diagram illustrating a side view of a medication injectionsite as in FIG. 4A;

FIG. 4C is a diagram illustrating a magnified view of a medicationcontainer having an alternate information source as in FIGS. 4A and 4B;

FIG. 4D is a diagram illustrating a second magnified view of amedication container having an alternate information source as in FIGS.4A and 4B;

FIG. 5 is a diagram illustrating a medication injection site and a datacollection system;

FIG. 6A is diagram illustrating a medication container containing aninformation source that can be optically detected;

FIG. 6B is a diagram illustrating a magnified view of elements shown inFIG. 6A;

FIG. 7A is a diagram illustrating a medication container containing aninformation source that has mechanical features;

FIG. 7B is a diagram illustrating a magnified view of elements shown inFIG. 7A;

FIG. 8A is a diagram illustrating a medication container having a radialinformation source as in FIG. 4A in greater detail;

FIG. 8B is a diagram illustrating an alternate location for a radialinformation source;

FIG. 8C depicts a magnified view of elements shown in FIG. 8A;

FIG. 8D is an alternate information source that fits around a portion ofa medication container;

FIG. 9A is a diagram illustrating a medication injection site with alinear first fluid channel intersected by a second fluid channel atright angle;

FIG. 9B is a diagram illustrating a medication injection site with afirst fluid channel intersected by a second fluid channel at right angleand a medication port coupled to the intersection of the first fluidchannel and the second fluid channel;

FIG. 9C is a diagram illustrating a medication injection site with afirst fluid channel intersected by a second fluid channel at an acuteangle;

FIG. 10A is a diagram illustrating a fluid delivery tubing set;

FIG. 10B is a diagram illustrating different locations for a fluiddelivery tubing set as in FIG. 10A;

FIG. 11A is a diagram illustrating a medication injection site with afluid flow measurement sensor on a first fluid channel;

FIG. 11B is a diagram illustrating a medication injection site with afluid flow measurement sensor on a second fluid channel;

FIG. 12 is a diagram illustrating a flow measurement calculation methoddescribed for use with a medication injection site as in FIGS. 11A and11B;

FIG. 13A is a diagram illustrating a first pressure-time graph for aflow measurement calculation method as in FIG. 12;

FIG. 13B is a diagram illustrating a second pressure-time graph for aflow measurement calculation method as in FIG. 12;

FIG. 14A is a diagram illustrating a data collection system with awireless data receiver and removable memory;

FIG. 14B is a diagram illustrating a data collection system with awireless data receiver, a display, and a recording system;

FIG. 15A is a diagram illustrating a first variation of medicationinjection site that includes a disposable sub-housing and a reusablesub-housing;

FIG. 15B is a diagram illustrating a second medication injection sitethat includes a disposable sub-housing and a reusable sub-housing;

FIG. 15C is a diagram illustrating a third medication injection sitethat includes a disposable sub-housing and a reusable sub-housing;

FIG. 15D is a diagram illustrating a fourth medication injection sitethat includes a disposable sub-housing and a reusable sub-housing;

FIG. 16A is a diagram illustrating a secondary medical device configuredto receive wireless information from a medication injection site;

FIG. 16B is a diagram illustrating a data collection system to receivewireless information from a medication site and from a secondary medicaldevice;

FIG. 16C is a diagram illustrating a data collection system configuredas a cellular phone to receive wireless information from a medicationinjection site and/or a secondary medical device;

FIG. 17 is a diagram illustrating a second identification sensor toreceive information from a second information source;

FIG. 18 depicts use of a second identification sensor to detectcomplementary information from a medication information source;

FIG. 19 is a diagram illustrating a fluid delivery tubing set connectedto a medication injection site for continuous infusions to a patient;and

Like reference symbols in the various drawings indicate like or similarelements.

DETAILED DESCRIPTION

FIG. 1 is a diagram illustrating a system 2 in which a healthcareprovider oversees the care of a patient. In particular, the healthcareprovider selects and administers medications from a stock or an array ofavailable medications. A medication container 20 can carry aninformation source 24 that provides detectable information indicative ofthe medication in the container and/or of the volume of the contents ofthe container. After selecting the appropriate medication, thehealthcare provider delivers it to medication injection site 3. Therecan be several routes for parenteral administration of medications. Onecan be located on tubing set 11 connected to the patient. Tubing setsare frequently used for delivering fluids to patients and can provide aconvenient access for manual medication injections as well as forcontrolled infusions. As shown in FIG. 1, the medication injection site3 can be positioned at different locations along tubing set 11. In someimplementations, the location can be close to the fluid source bag(e.g., saline bag, etc.) where the medication injection site 3 isaffixed to or acts as a “Y” site on the tubing set 11. Here, pharmacyprepared admixtures can be attached to an IV tubing set. Alternately,medication injection site 3 can be in the form of an extension setlocated lower on tubing set 11 closer to the patient's infusion site.This site can be used for IV bolus injections where prompt medicationdelivery to the patient is important for acute care situations. Stillother forms of medication injection site 3 can include direct bolusinjection to a patient by attaching medication injection site 3 to acatheter or needle with little or no intermediate tubing (e.g., 10 cm orless, etc.). Here, medication is directly injected into the patientthrough a single fluid channel within medication injection site 3.Emergency medications, insulin, pain medications may use thisadministration method and are typically followed by a saline flush.

In any of the above medication injection site locations, a sensor atleast partially enclosed by housing 4 of medication injection site 3 candetect the presence and type of medication container 20 and transmitinformation 36 via wireless communications to data collection system 6.Medication injections (from one or more medication containers 20) can betime stamped and recorded in a history log and/or added to the patient'smedical records and/or billing records. The healthcare provider can viewon a display of data collection system 6 which medication has beeninjected into the patient and when such medication was administered.Immediate display of information assists the healthcare provider inmaking further medication decisions for the care of the patient.

FIGS. 2A and 2B are diagrams illustrating medication injection site 3with medication container 20 in a spatially separated state (FIG. 2A)and a coupled state (FIG. 2B). In this variation, the medicationinjection site 3 can include a first fluid channel 8 and a second fluidchannel 10 (other channels may be included in some implementations).Housing 4 of medication injection site 3 can include both the firstfluid channel 8 (continuous fluid channel connecting the fluid source tothe patient) and the second channel 10 (injection port fluid channel)joining the first fluid channel forming an intersecting junction 15. Thefirst and second fluid channels 8, 10 may be fully enclosed by thehousing 4 or one or both may extend outwards from the housing (e.g., ifthe fluid channels 8, 10 comprise flexible tubing with connectionadapters for coupling to further tubing). The first and second fluidchannels 8, 10 are sometimes collectively referred to herein as a fluidjunction element. In some variations, the fluid junction element cancomprise a unitary element (e.g., injection molded material, etc.). Withother variations, the fluid junction element can comprise a plurality ofsections (i.e., it is non-unitary) and/or is integrated with the housing(e.g., sections of the housing form the fluid paths).

The first fluid channel 8 can extend from a first end 12 to a second end14. The second fluid channel 10 can extend from an opening of medicationport 13 at a distal end and can terminate at the first fluid channel 8at intersection 15 intermediate the first end 12 and second end 14. Themedication port 13 can be configured to fluidically couple to a fluidoutlet 17 of medication container 20.

An identification sensor 18 can be at least partially disposed withinhousing 4 (i.e., the identification sensor 18 can be enclosed by thehousing 4 or a portion of it can extend outwards from an outer surfaceof the housing 4, etc.) to generate information indicative of contentsand/or volume of contents of medication container 20. In somevariations, the identification sensor 18 can generate such informationwhen fluid outlet 17 of medication container 20 is fluidically coupledto medication port 13. In other variations, the identification sensorcan generate such information when fluid outlet 17 of medicationcontainer is adjacent to medication port 13. A transmitter 34 can bedisposed within housing 4 and in communication with and/or coupled toidentification sensor 18 to wirelessly transmit the information 36generated by the identification sensor 18 to the remote data collectionsystem 6. Examples of wireless transmission hardware and protocols canbe utilized such as Bluetooth, Zigbee, Continue, Wireless USB, Wibree,IEEE 802 relevant standards (e.g., 802.11, 802.15, or 802.16, etc.) andother methods. The data transmissions can, in some implementations, beencrypted in order to ensure patient privacy and/or to comply withvarious laws relating to handling of medical data. The transmitter 34can have such encryption capabilities or one or more additional chipsetscan be incorporated within the medication injection site 3 to providesuch encryption. The signal from identification sensor 18 can beprocessed and readied for transmission by sensor circuit 30. Aself-contained power source 19 (e.g., battery or battery array, etc.)can be disposed within housing 4 to provide power for one or more ofidentification sensor 18, sensor circuit 30 and transmitter 34.

Housing 4 and/or the entire medication injection site 3 can have a shapeand size enabling it to be hand-held by a first hand of a user while theuser administers medication from medication container 20 via the fluidoutlet 17 using his or her second hand. The housing 4 and/or the entiremedication injection site 3, excluding any external tubing can, in someimplementations have a largest dimension of 10 centimeters or less. Inaddition, the entire housing 4 and its contained components and/or theentire medication injection site 3 can be lightweight being less than 1kg, and in some implementations, less than 100 grams and in someimplementations less than 50 grams. The compact and/or lightweightnature of the medication injection site 3 allow it to be suspended belowthe fluid source at a Y-site (or to replace a Y-site) and supported bythe tubing set 11 during use (see diagram of FIG. 10B). Alternately, thesmall size and weight can facilitate use on tubing set 11 closer to apatient's injection site and can be conveniently secured to thepatient's arm (see diagram FIG. 2C).

In some implementations, housing 4 can be separated into twosub-housings (see diagrams FIGS. 15A, 15B, 15C, 15D). A reusablesub-housing 80 can house reusable elements (i.e., elements that can besafely used among several patients, etc.) while a disposable sub-housing82 can house disposable elements (i.e., low-cost and/or sterile elementsthat are recommended for use in connection with a single patient, etc.).The sub-housings can be operatively coupled by connecting element 84thus forming a fully functional injection site 3.

Housing 4 can be made of a rigid material that protects the componentcontained within the housing 4 from handling and fluids during use.Housing 4 can rigidly position and fix its contained components relativeto each other. Housing 4 can be made by plastic injection molding amaterial such as polystyrene or polycarbonate to form one or more piecesof the housing. Sections of the housing 4, can in some implementations,form the first fluid channel 8 and the second fluid channel 10. In onevariation, the entire housing 4, including the medication port 13, thefirst and second channels 8, 10 and internal components can be providedsterile with protective sterility covers on the first end 12 and thesecond end 14 of first fluid channel 8 as well as medication port 13.

All or some of the components of the medication injection site 3 can beselected so as to withstand conventional single use medical devicesterilization processes such as EtO or radiation. The medicationinjection site 3 can be packaged with sterility covers in place in apeel-pouch kit configuration and provided to the user with a sterilefluid delivery pathway ready for use with sterile medications and/orfluids. Instruction for use and/or other identifying materials may beincluded with the medication injection site 3 to form a kit.

Removal of one or more of the sterility covers on medication injectionsite 3 can result in the self-contained power source 19 powering one ormore of the transmitter 34 and the sensor circuit 30. Initial power-upsequences can synchronize communications between transmitter 34 andreceiver 42 (see FIG. 5). Indicator 35 (see FIG. 5) can indicatereadiness for medication delivery and data collection system 6 canindicate the start of medication record keeping. In some implementationsLED emitter 32 can provide user readiness information similar to thefunction of indicator 35. LED emitter 31 can illuminate housing 4 and/ormedication injection site 3 with a visual alert (e.g., blinking light,etc.) thus drawing user attention to the injection port and itsreadiness for operation. Later, when medication container 20 is coupledto medication injection site 3 LED emitter 31 (or indicator 35) canilluminate medication site 3 and the fluid outlet of medicationcontainer 20 in a steady ON state indicating successful fluid couplingand identification member detection. Other visual indicators such ascombinations of blinking and/or steady ON can indicate variousoperational states of the injection port.

FIGS. 2C and 2D are diagrams illustrating medication injection site 3with medication container 20 in a coupled state. In these variations,the medication injection site 3 does not include a first fluid channel 8as part of injection site 3. Only the second fluid channel 10 isincluded. The second fluid channel 10 can be fully enclosed by thehousing 4 or can extend outwards from the housing. Additionally, otherelements can be included in housing 4 which will be described later.These can include check valve 23, indicator 35, memory element 38 and/orclock 39. Medication injection site 3 can be single use and fullydisposable. In a different variation, medication injection site 3 can beseparable into a disposable portion and a reusable portion as will bediscussed in FIGS. 15A-15D.

FIG. 2C depicts housing 4 directly coupled to a “Y” site of an IVinfusion tubing set 11. The second fluid channel 10 can extend from anopening of medication port 13 at a distal end and can terminate at thefluid outlet end 14. Second channel 10 can include a length of fluiddelivery tubing to allow positioning of housing 4 for user convenience.The medication port 13 can be configured to fluidically couple to afluid outlet 17 of medication container 20 (see FIG. 2A). Fluid channel10 can include check valve 23 to limit fluid backflow from the “Y” siteof infusion tubing set 11 into fluid channel 10. Alternately, checkvalve 23 can be included in medication port 13 and take the form of aswab-able needleless injection connector facilitating a luer connectionfrom medication injection site 3.

An identification sensor 18 can be disposed within housing 4 to generateinformation indicative of contents and/or volume of contents ofmedication container 20. In some variations, the identification sensor18 can generate such information when fluid outlet 17 of medicationcontainer 20 is fluidically coupled to medication port 13. In othervariations, the identification sensor can generate such information whenfluid outlet 17 of medication container is adjacent to medication port13. A transmitter 34 can be disposed within housing 4 and incommunication with/coupled to identification sensor 18 to wirelesslytransmit the information 36 generated by the identification sensor 18 tothe remote data collection system 6. The signal from identificationsensor 18 can be processed and readied for transmission by sensorcircuit 30. A fluid delivery sensor 60 can be included in housing 4 toprovide information indicative of fluid flow and/or a volumecharacteristic. The signal from fluid delivery sensor 60 can beprocessed and readied for transmission by sensor circuit 30. Information36 indicative of fluid flow and/or volume can be transmitted bytransmitter 34 to data collection system 6. A self-contained powersource 19 (e.g., battery or battery array, etc.) can be disposed withinhousing 4 to provide power for one or more of identification sensor 18,fluid delivery sensor 60, sensor circuit 30, transmitter 34 andindicator 35.

Housing 4 and/or the entire medication injection site 3 can have a shapeand size enabling it to be hand-held by a first hand of a user while theuser administers medication from medication container 20 via the fluidoutlet 17 using his or her second hand. The housing 4 and/or the entiremedication injection site 3, can in some implementations have a largestdimension of 10 centimeters or less. In addition, the entire housing 4and its contained components and/or the entire medication injection site3 can be lightweight being less than 100 grams, and in someimplementations, less than 50 grams. The compact and/or lightweightnature of the medication injection site 3 allow it to be suspended belowthe fluid source attached to an upper Y-site and supported by the tubingset 11 during use. Alternately, the small size and weight can facilitateuse on tubing set 11 attached to a lower “Y” site closer to a patient'sinjection site and can be conveniently secured to the patient's arm.

FIG. 2D depicts housing 4 directly coupled to a needle for directinjection to a patient. The second fluid channel 10 can extend from anopening of medication port 13 at a distal end and can terminate at thefluid outlet end 14. Second channel 10 can include a length of fluiddelivery tubing to allow positioning of housing 4 for user convenience.The medication port 13 can be configured to fluidically couple to afluid outlet 17 of medication container 20. Additionally, other elementscan be included in housing 4 which will be described later. These caninclude check valve 23, indicator 35, memory element 38 and/or clock 39.

An identification sensor 18 can be disposed within housing 4 to generateinformation indicative of contents and/or volume of contents ofmedication container 20. In some variations, the identification sensor18 can generate such information when fluid outlet 17 of medicationcontainer 20 is fluidically coupled to medication port 13. In othervariations, the identification sensor can generate such information whenfluid outlet 17 of medication container is adjacent to medication port13. A transmitter 34 can be disposed within housing 4 and incommunication with/coupled to identification sensor 18 to wirelesslytransmit the information 36 generated by the identification sensor 18 tothe remote data collection system 6. The signal from identificationsensor 18 can be processed and readied for transmission by sensorcircuit 30. A fluid delivery sensor 60 can be included in housing 4 toprovide information indicative of fluid flow and/or a volumecharacteristic or a medication type composition sensor. The signal fromfluid delivery sensor 60 can be processed and readied for transmissionby sensor circuit 30. Information 36 indicative of fluid flow and/orvolume and/or medication type can be transmitted by transmitter 34 todata collection system 6. A self-contained power source 19 (e.g.,battery or battery array, etc.) can be disposed within housing 4 toprovide power for one or more of identification sensor 18, fluiddelivery sensor 60, sensor circuit 30, transmitter 34 and indicator 35.

The fluid delivery sensor 60 shown in FIG. 2D can be a medicationcomposition sensor to provide verification of the type of fluid injected(the medication composition sensor can be one or more sensors that areseparate and distinct from the fluid delivery sensor 60). Medicationcomposition sensor 60 can be based on and include, but not limited totechnologies such as: photometric analysis, electrometric analysis,chromatography, mass spectroscopy, physical property measurements, pHdetection, viscosity indication, optical density indication, chemicalindication, drug molecule indication, spectrophotometer measurement,HPLC detection, UV detection, fluid density measurement, specificgravity measurement, or parametric analysis based on a combination ofthe previously listed technologies. Alternately, or in combination withthe above, the composition sensor 60 can be a combination of a number ofmeasured parameters, including but not limited to the above parameters,that populate a table with values indicative of the medication. Thetable can be included in medication injection site 3 or data collectionsystem 6. The table can be compared to a stored look-up table with aknown set of parameter values for a specific medication type andconcentration to determine the actual medication type and/orconcentration of the fluid injected.

Housing 4 and/or the entire medication injection site 3 can have a shapeand size enabling it to be hand-held by a first hand of a user while theuser administers medication from medication container 20 directly to thepatient through a needle. In another embodiment, the housing can have asize and shape enabling it to be used by one hand, either by securing itto a surface with pressure from the hand or utilizing a mountingfixture. Alternately, the needle shown in FIG. 2D can be inserted into a“Y” site of infusion set 11 as shown in FIG. 2C.

FIGS. 3A-C depict various features of the medication injection site 3.With reference to FIG. 3A, the first end 12 of first fluid channel 8 canbe attached to a fluid source through tubing set 11 and the second endof first fluid channel 8 can be attached to a patient through tubing set16. While tubing sets 11 and 16 are illustrated as being separate, somevariations include a single tubing set extending through the housing 4.First fluid channel 8 can join first end 12 (i.e., fluid inlet) andsecond end 14 (i.e., fluid outlet) forming a fluid path inside housing4. First fluid channel 8 can be joined by second fluid channel 10 atintersection 15 for the administration of medication from container 20.Intersection 15 can be positioned such that the relationship between thefirst fluid channel 8 and the second fluid channel 10 is a right angleas shown in FIG. 3A substantially forming a “T”-shape. Alternatively,the channels 8, 10 can be positioned to form an acute angle. In someimplementations, the angle is such that the first fluid channel 8 andthe second fluid channel 10 form a “Y” shape.

A check valve 22 can be situated in the first fluid channel 8 upstreamof intersection 15 to prevent fluid backflow upstream into the fluidsource when the medication container 20 is delivering fluid intomedication port 13. The second fluid channel 10 can contain a checkvalve 23 to prevent fluid flow from the first fluid channel 8 fromflowing into the second fluid channel 10.

Medication container 20 can be a syringe or other medication containersuch as a vial with compatible fluid coupling of outlet 17 on medicationcontainer 20 to medication port 13 (e.g., a slip luer, luer-lockfitting, a vial adapter spike, etc.). Medication container 20 caninclude information source 24 located on the fluid outlet attachment tipof container 20. Such information source 24 can, in some implementationsbe affixed, integrated, secured, and/or adhered to a portionintermediate the fluid outlet of medication container 20 and a barrelportion of container 20. Such intermediate portion can be tapered and/orplanar. The information source 24 can be an integrated feature of themedication container 20 such as etched or molded features. Theinformation source 24 can alternatively be adhered to the fluid outletattachment tip of medication container 20 (i.e., information source 24can be a label, etc.). In addition, the information source 24 can be aseparate element that extends around the fluid outlet of the medicationcontainer 20 (applied either during manufacture of the medicationcontainer or subsequently whether during distribution or use).

When provided to a user, medication port 13 can be protected by portcover 21. Prior to use, the port cover 21 maintains medication port 13in a sterile condition. Similarly, when provided as an extension set(i.e., medication injection site 3 includes added tubing that increasesfunctional capability of fluid administration line and extends the fluidtubing set 11), sterility covers can be provided on the first end 12 andthe second end 14 of the first channel 8. When used, the medicationinjection site 3 can be connected to the fluid source by removing thesterility cover on the first end 12 and attaching tubing set 11.Secondly, the sterility cover can be removed from the second end 14,fluid flow is then established through first fluid channel 8 and thensecond end 14 is connected to tubing 16. Tubing 16 can then be attachedto a patient's catheter for delivery of fluids and medications.

The identification sensor 18 can include an optical emitter/detectorpair 31 with horizontal orientation on sensor 18 that detects encodedinformation contained on information source 24 (a sleeve around thefluid outlet of the medication container 20) parallel to the fluidoutlet axis. The identification sensor 18 can comprise a plurality ofsensors to detect information source 24. In some variations, theidentification sensors can be sensors such as optical, magnetic,mechanical, conductive, switchable RFID and/or proximity sensors. Inother variations, identification sensor 18 can be optical and caninclude an illumination source (emitter) such as an LED and a detectionsource (detector) such as a camera (CCD). Sensor circuit 30 can providesignal processing and connects identification sensor 18 to transmitter34. The identification sensor 18 can be directly coupled to power source19.

FIG. 3B depicts a side view of medication injection site 3. Housing 4 issized and shaped to easily fit into a user's hand. The location ofmedication port 13 can be anywhere along the length of first channel 8and conveniently positioned for ease of use.

FIG. 3C is an enlarged view of medication port 13 showing identificationsensor 18 having a concentric (or at least partially concentric)configuration so that it can surround information source 24 on theoutlet 17 of medication container 20. When medication container 20 iscoupled to the medication injection site 3, outlet 17 is fluidicallycoupled to medication port 13 and information source 24 issimultaneously positioned for detection within and in close proximity toidentification sensor 18.

FIGS. 4A, 4B, 4C and 4D depict an alternate implementation ofinformation source 24 and identification sensor 18. FIG. 4A depicts across-sectional view of medication container 20 coupled to a medicationinjection site 3. FIG. 4B is a side view. The medication injection site3 can include an optical emitter and detector pair 31 positioned andconfigured to optically detect encoded information 29 on informationsource 24. Information source 24 can take the form of a disk or otherelement with an opening mounted over the fluid outlet perpendicular tothe fluid outlet axis. Information source 24, when taking the shape of adisk, can be substantially planar and include an inner opening 27 (see,e.g., FIGS. 4A, 4C, 4D) that corresponds to fluid outlet 17 ofmedication container 20. Such an information source 24 can be mounted tomedication container 20 so that inner hole 27 is concentric with fluidoutlet 17 (and positioned so that medication container 20 can still becoupled to medication injection site 3 and medication can be delivered).

As shown in FIGS. 4C and 4D when used, information source 24 andmedication container 20 can be rotated together clockwise to completethe fluid coupling of fluid outlet 17 to medication port 13. Barcodeindicia 29 are also correspondingly rotated. The opticalemitter/detector pair 31 can scan (i.e., illuminate and detect) therotated barcode indicia 29 and extract the identifying information. Suchidentifying information can then be passed from sensor circuit 30 totransmitter 34 for transmission.

In some implementations, the identification sensor 18 can include aseries of more than one sensor to detect information source 24. Inaddition, the identification sensors can be other types of sensors suchas optical, magnetic, mechanical, conductive, switchable RFID and/orproximity sensors. With non-optical arrangements, the correspondinginformation source 24 and the detector 31 would be correspondinglymodified. For example, if information source 24 comprises a magneticstrip, detector can be a magnetic strip reader. In addition, sensorcircuit 30 provides signal processing and connects identification sensor18 to transmitter 34.

FIG. 5 depicts additional elements of system 2 including a medicationinjection site 3 with a centrally located second fluid channel 10,further elements contained within data collection system 6 andconnection to a medical information system 52. Medication injection site3 can include information processing and transmission circuit 32.Signals from sensor circuit 30 can be processed for transmission to datacollection system 6 by circuit 32. Sensing circuit 30 can generate oneor more signals in response to connection of medication container 20 tomedication port 13. When identification sensor 18 detects connection ofmedication container 20 a visual and/or audible indicator 35 can beactuated to provide feedback to the user of proper connection.Transmitter 34 can transmit information 36 to receiver 42 contained indata collection system 6. When transmitter 34 transmits information 36to receiver 42 a visual and/or audible indicator 35 can be actuated toprovide feedback to the user of proper transmission.

The sensor circuit 30 can contain a Hall Effect sensor 33 that detectsthe completion of medication administration when magnetic indicator 26is in close proximity to sensor 33. Alternatively, sensor 33 andindicator 26 can be optical, mechanical, conductive and/or or proximitysensor/detector pairs and provide a medication administration completesignal to circuit 32. In this case, a second information transmission 36can be sent to receiver 42 in response to a signal from sensor 33. Whentransmitter 34 transmits information 36 to receiver 42 a visual and/oraudible indicator 35 can be actuated to provide feedback to the user ofproper transmission of the completion of medication administration.

Medication delivered from medication container 20 can flow via outlet 17into the second fluid channel 10, past check valve 23 and into firstfluid channel 8. Fluid from the fluid source enters first fluid channel8 at first end 12, flows past check valve 22 and out to the patientthrough second end 14 and tubing 16.

Data collection system 6 receives information 36 (e.g., packetized data,etc.) from transmitter 34 within the medication injection site 3. In onevariation, data collection system 6 can include a personal computer (seeFIG. 14A). In another variation, the data collection system 6 can besmall, light weight and configured to be stand-alone with aself-contained power source 43 (see FIG. 14B). The data collectionsystem 6 can be portable so that it can, for example, provide medicationadministration information for emergency medical services personnel inthe field or it can be used on mobile crash carts, automated medicationdispensing units or other medication storage systems by health careproviders within a hospital, other healthcare facility or within ahomecare environment. In one implementation, after medications aredelivered (or during delivery) and the health care protocol is completedata collection system 6 can be connected (e.g., via a web service,wirelessly, or direct connection, etc.) to medical information system 52for records transfer and/or data storage and/or patient billing, etc.

The data collection system 6 and/or the medication injection site 3 caninitiate wireless exchange of information. Appropriatediscovery/handshaking message exchanges are used to initiatecommunications (whether when the medication injection site 3 is firstused or when there is an interruption of communications, etc.). Themedication injection site 3 can interface with multiple data collectionsystems 6 at one time or simply pass information from a first datacollection system 6 to subsequent data collection systems 6 (using, forexample, memory resident in the medication injection site 3 as describedbelow).

Within data collection system 6, information received by receiver 42 issent to and processed by circuit 44. Circuit 44 contains a messagedecoder and display driver circuit 46, a micro-computer 47, aninformation display and recording system 48 and clock 49. Informationreceived is time stamped by clock 49, logged into memory and displayedby circuit 48. Information displayed and recorded can include one ormore of: the type and amount of medication delivered, time of medicationadministration, sequence of medications delivered, prompting messagesproviding real-time feedback to the healthcare provider on priormedications delivered, prompting messages for future medications to beadministered with proposed protocol administration times, time since themedication was administered and other instructive information forconducting the health care protocol.

Display and recording system 48 can receive messages and generate arecord documenting the time sequence of medication injections based uponsignals received from sensor circuit 30. Display and recording system 48can, in some variations, include a report generator capable of sendingreport information 50 to a medical information system 52. A user 54 caninteract with micro-controller 47 via user interface 56 to provideadditional information to the display and recording system 48.Additionally, user 54 can edit the report, add non-medicationadministration information to the report and complete printing or filingof the report to a medical information system 52. Medical informationsystem 52 may be coupled to a local network and/or accessible via theInternet.

Display and recording system 48 can take the received information 36 andcombine it with time information from clock 49 to generate a timestamped information log. Computer system 47 can receive the time stampedinformation for each medication injection. The medication informationincluded in the time stamped log file can include, but is not limitedto, type of medication, volume of medication injected, expiration dateof the medication, medication manufacturer's information and user editedreport information. Such information can be integrated with medicalfiles for the patient and/or submitted to a patient billing system(e.g., by web service, etc.).

The message decoder and display driver circuit 46 can convert eachsignal into an encoded value indicative of the medicationadministration. The encoded value can then be provided to computersystem 47 that decodes the value and provides the user withunderstandable information about the injections for editing.

In some implementations, the medication injection site 3 can containmemory 38 to store medication administration data. The data can includea sequential record of each medication administration made throughmedication injection site 3. Timer 39 provides time count data to memory38 separating each successive medication administration data element.Situations that can occur necessitating the use of memory 38 and timer39 include: failure of data collection system 6, inadvertent userfailure to activate data collection system 6, transfer of a patient fromone data collection system 6 to another during transfer of the patientto different health care providers (field emergency medical service careprovider to ambulance care provider to hospital emergency room careprovider, etc.). In these situations the patient's medicationadministration data is stored in memory 38 and can be recalled later bya different data collection system 6. The memory 38, in someimplementations, can be removable allowing it to be accessed by acomputing system. For example, the memory 38 can be part of a USB cardallowing it to be removed and accessed by a separate computing system.In some variations, the memory 38 can store software to either launch alocal application on such separate computing system or to launch aparticular web site or initiate a web service. In either of suchscenarios, the patient data can be transported for storage and/ordisplay on such separate computing system (or to another computingsystem remote from such separate computing system).

Various types of medication containers 20 can be used with themedication injection site 3, provided, that the fluid outlet 17 of themedication container can couple to the medication port 13. FIGS. 6A-8Cillustrate various arrangements such as syringes and reverse syringes.Other containers (not shown) can be in the form as discussed earlier.

FIGS. 6A and 6B depict a medication injection site 3 with some elementsremoved for illustration purposes. FIG. 6A illustrates top and frontviews of housing 4 to the left with medication container 20A about to becoupled to medication port 13. A side view is depicted on the lowerright with medication container 20A fully engaged with medication port13. Fluid inlet first end 12 and fluid outlet second end 14 can beconnected by first fluid channel 8. Fluid inlet 12 and fluid outlet 14can be a slip luer, luer-lock or other fluid delivery fitting connectorsand are typically fitted with sterile protective caps prior to use.Second fluid channel 10 can join first fluid channel 8 at intersection15 Medication port 13 is initially provided for use with a sterilebarrier cap 21 which is removed immediately prior to medicationinjection. Alternately, medication port 13 can be a swab-able needlelessinjection connector facilitating a luer connection from a syringe orother medication container 20. In some variations, the medicationcontainer 20 can include a needle or an outlet port adapter which actsas the outlet 17 which in turn is fluidically coupled to the medicationport 13.

The housing 4 can at least partially enclose identification sensor 18,sensor circuit 30, transmitter 34 and a common power source 19 (battery,battery array, etc.). Sensor circuit 30 can provide for one or moreidentification sensors 18 (and/or 218 in FIG. 17) to detect informationfrom medication information source 24 (and/or complementary informationsource 224 in FIG. 17). Transmitter 34 can process the sensor signalsand transmits them to a data collection system 6.

In FIG. 6A medication container 20A can be a syringe with a fixedmedication container and a slidable plunger 25 which moves duringmedication administration. Medication container (A) 20A can have amedication information source 24 affixed on the tip. There can be anumber of variations (a, b, c, d) for information source 24. Informationsource 24 a can contain information (e.g., readable data, etc.)indicative of the medication in one or more horizontal bands.Information source 24 b contains information indicative of themedication in one or more vertical bands. Information source 24 ccontains information indicative of the medication in a combination ofone or more horizontal and vertical bands. Information source 24 d cancontain information indicative of the medication in one or more dots ina two dimensional dot matrix pattern.

Additionally, plunger 25 can contain a ferric material 26A that can bedetected by a magnetic sensor 33. The ferric material 26A can be amagnet or other type iron material matched with ferric material typesensor 33. When the medication delivery is completed plunger 25 withferric material 26A comes into close proximity with sensor 33 and amedication administration complete signal is sent to circuit 32.Transmitter 34 then relays the information to receiver 42 for datacollection. Other materials/devices may be used to detect relativeposition of the plunger 25.

With reference to the upper right portion of FIG. 6A, information source24 can be an RFID tag with an antenna that can be connected ordisconnected by a switch. With this arrangement, a switchable RFID taginformation source 24 can be provided with the antenna disconnected.When medication container 20 is connected to medication port 13 theantenna becomes connected (switched ON) and the information source 24can be read by an RFID reader identification sensor 18 within housing 4.

FIG. 6B is a magnified view showing a fully engaged information source24 in close proximity to emitter (E) and detector (D) elements ofidentification sensor 18 shown on the left or emitter LED (E) anddetector camera (CCD) elements 31 of identification sensor 18 shown onthe right and Hall Effect sensor 33 all contained within the housing 4.

FIGS. 7A and 7B illustrate medication container 20B and injector housing21B being a reverse syringe design wherein plunger 25 remains fixedrelative to the motion of medication container 20B during medicationadministration. FIG. 7A on the left shows the medication container 20Bwith medication information source 24 affixed on the luer fitting tipbefore connection to medication port 13. Similar to medication container20A, there can be a number of mechanical embodiments (a, b, c) forinformation source 24 on medication container 20B. Additionally,medication container 20B can contain an indicator 26B that can be ferricmaterial that can be detected by magnetic sensor 33. The ferric material26B can be a magnet or other type iron material matched with ferricmaterial type sensor 33. Other types of indicators such as optical,capacitive, mechanical, etc. which are not ferric based can be used toindicate the completion of medication administration. When themedication delivery is completed as shown to the right medicationcontainer 20B with ferric material 26B comes into close proximity fordetection by sensor 33 and a medication administration complete signal(or other data) can be sent to circuit 32. Transmitter 34 then relaysthe information to receiver 42 for data collection.

Indicator 26B can, in some implementations, be a switchable RFID tagwith an antenna that can be connected or disconnected (see FIG. 6A). Inthis variation, an RFID tag indicator 26B can be provided with theantenna disconnected. When medication container 20B is fully displacedthe antenna can become connected (switched ON) and the medicationdelivered indicator 26B can be read by an RFID reader within sensorcircuit 30.

FIGS. 7A and 7B illustrate a variation in which information source 24comprises a collar 24 c with mechanical indicator pegs. FIG. 7Aillustrates top and front view of housing 4. As shown to the left,medication container 20B is about to be coupled to medication port 13. Aside view is depicted in the lower right such that medication container20B is fully engaged with medication port 13. Collar 24 c can have oneor more indicator pegs arranged such as to indicate the type ofmedication contained in medication container 20B. Any number of pegsand/or peg patterns (a, b, c) can be used as an indication of the typeof medication contained. Housing 4 can include a receiver identificationsensor 18 r that has opening holes to receive the pegs on collar 24 c.Any number of opening patterns (a, b, c) can be used as an indication ofthe type of medication contained, the volume of medication, and/orexpiration data. When properly engaged, pegs on collar 24 c mate withreceiver identification sensor 18 r openings and form the medicationinformation transfer. The pattern indicated is detected byidentification sensor 18 and a signal can be sent to circuit 32.Transmitter 34 can then relay the information to receiver 42 for datacollection.

Information source 24 c can alternatively have external indicator ribs(or similar type of protrusions). Information source 24 c can have oneor more indicator ribs arranged such as to indicate the type ofmedication contained in medication container 20B or other relevantinformation. Any number of ribs and/or rib patterns (a, b, c) can beused as an indication of the type of medication contained. Housing 4 caninclude a receiver identification sensor 18 r that has opening notchesto receive the ribs on information source 24 c. Any number of openingpatterns (a, b, c) can be used as an indication of the type ofmedication contained. When properly engaged, ribs on information source24 c can mate with receiver identification sensor 18 r notches or otherfeatures. The pattern indicated by receiver information source 18 r canbe detected by identification sensor 18 so that a signal containing datacharacterizing the medication container 20 is sent to circuit 32.Transmitter 34 then relays the information to receiver 42 for datacollection.

FIG. 7B is diagram illustrating a magnified view showing a fully engagedinformation source 24 in close proximity to emitter (E) and detector (D)elements 31 of sensor circuit 30 and sensor 33 all contained within thehousing 4. Information source 24 c can have protrusions (in this casefour pegs) protruding from the collar 24 c. Receiver identificationsensor 24 r can mate with pegs on information source 24 c facilitatingdetection of the medication information by emitter (E) and detector (D)sensors mounted on sensor circuit 30. Additionally, sensor 33 is shownlocated on the uppermost part of housing 4 for the detection of ferricmaterial 26B.

FIGS. 8A, 8B and 8C depict a variation of information source 24. FIG. 8Adepicts information source 24 formed as a flat disk mounted to the fluidoutlet 17 of medication container 20. Information sensor 18 can beoriented vertically and detect information when medication container 20is rotated about the fluid outlet axis. Information can be encoded usingoptical or magnetic methods. In one implementation, the informationsource 24 can carry a radial barcode pattern 29. Emitter/detector pairs31 can detect information and signals can be provided to sensor circuit30 that characterize the medication container 20. An alternateinformation source (a two dimensional barcode) and emitter/detector pair31 (LED and Camera CCD) is shown in FIG. 4D

FIG. 8B depicts information source 24 as a cylindrical/circumferentialband having an outer surface that is mounted to the fluid outlet 17 ofmedication container 20. Information sensor 18 can be orientedhorizontally and detect information when medication container 20 isrotated about a fluid outlet axis. Information can be encoded usingoptical or, magnetic methods. The band can have a barcode pattern thatextends along the cylindrical surface at a constant radius.Emitter/detector pairs 31 can detect information and signalscharacterizing the medication container 20 can be provided to sensorcircuit 30.

FIG. 8C depicts a magnified view of elements shown in FIG. 8A. Anattachment material 37 can be interposed between medication container20. The attachment material 37 can configured to be releasable from afirst medication container and re-attached to a second medicationcontainer. The attachment material can be an adhesive material or a snapin place mechanical material. Alternately the information source 24(disk or cup) can include gripping or latching type teeth on the innerdiameter 27 of information source 24. This feature can be used when anoriginal medication container 20 (medication vial) is provided without afluid outlet and a second medication container 20 (syringe) is used towithdraw medication from the first medication container 20 (vial) foruse with medication injection site 3. The information source 24originally provided with the first medication container (vial) can beremoved and then attached to the second medication container (syringe)during the medication transfer process. The contents of the secondmedication container 20 can be injected into the medication port 13 andinformation can be detected by information sensor 18.

The medication container can be a first medication container and theidentification member can be releasably secured to the medicationcontainer to allow it to be removed for placement on a second medicationcontainer. The identification member can bear an attachment elementallowing it to be removed from the first medication container andaffixed to the second medication container. Transfer of theidentification member from the first medication container to the secondmedication container can be completed during the process of transferringthe medication from the first medication container to the secondmedication container.

FIG. 8D depicts an alternate information source 24 in the shape of a cupsimilar to information source 24 in FIG. 8B except that the informationsource 24 cup fits around the luer tip of the medication containeroutlet and can be detected by information sensor 18 mounted horizontallyas shown in FIG. 8C. Information source 24 cup can attach and detach ina similar way as information source 24 disk to attachment material 37.

FIGS. 9A, 9B and 9C depict top and front views of alternate constructionembodiments of the fluid junction elements and housing 4. FIG. 9A showshousing 4 with a straight through first fluid channel 8 with a sideaccess for medication port 13. FIG. 9B shows housing 4 with a rightangled first fluid channel 8 with a side access for medication port 13.FIG. 9C shows housing 4 with a “Y” first fluid channel 8 and a straightthrough medication port 13. Various other configurations can beconstructed with different positioning of inlet 12, outlet 14 andmedication port 13 to facilitate any requirements of the clinicalset-up, orientation of hospital equipment, and/or medical practitionerpreference. FIG. 9A depicts a configuration that is a typical extensionset facilitating an in-line attachment from tubing set 11 to a patient'scatheter. FIG. 9B depicts a configuration that facilitates connection toa manifold (outlet 14) and allows straight through injections intomedication injection port 13. FIG. 9C depicts a configuration that is atypical “Y” site arrangement facilitating location of medication port 3on tubing set 11.

FIGS. 10A and 10B depict alternate variations for housing 4 as mountedon fluid delivery tubing sets. FIG. 10A depicts a “Y” site adapterconfiguration. Here inlet 12 and outlet 14 can be separated by anextended conduit 8 to form an extension set. FIG. 10B depicts a completefluid delivery tubing set with inlet 12 being a fluid bag spike andoutlet 14 a connector to a patient access device. The housing 4 can belocated near the fluid source bag at an upper “Y” site or nearer thepatient at a lower “Y” site location. Multiple configurations (e.g., twoor more medication injection sites used for a single patient, etc.)allow for greater access for tubing set medication injection duringmedical procedures when several practitioners are simultaneously workingon a patient (and access to one particular medication injection site maybe impeded). Other configurations can be utilized as a function of theclinical setting physical space and access to the tubing set.

FIGS. 11A and 11B depict a medication injection site 3 incorporatingfluid flow sensor 60. The fluid flow sensor 60 can be a pressuremeasurement sensor with differential pressure inlets 62 and 64 that arefluidically connected to first fluid channel 8. Pressure transducer 66can provide a differential pressure signal 70. When medication container20 delivers fluid to the second fluid channel 10 there is a suddenincrease in differential pressure signal 70 due to the fluid flowthrough orifice 68. This change in differential pressure indicates fluiddelivery from medication port 13 is occurring. The value of differentialpressure signal 70 can be provided to transmitter 34 and subsequentlytransmitted to receiver 42 as shown in FIG. 5. Pressure signal 70 can besent to message decoder & display driver 46. Micro-computer 47 cancontain algorithms to calculate fluid volume delivered based on thedifferential pressure. When the volume delivered equals the originalvolume in container 20 the end of medication delivery is logged. Knowingdifferential pressure, time, cross-sectional area of orifice 68 andcross-sectional area of first fluid channel 8 enables calculation offluid volume delivered.

A variation of the medication injection site 3 system of FIG. 5 is shownin FIG. 11B and depicts a construction with the pressure transducer 66positioned on second fluid channel 10 instead of on first fluid channel8. Fluid inlets 62 and 64 can be located down stream or upstream ofcheck valve 23. In this configuration, orifice 68 is located in secondfluid channel 10 between inlets 62 and 64. Volume delivered iscalculated in the same way as above using algorithms in micro-computer47.

In other constructions, the fluid flow sensor 60 can include a singlechannel pressure transducer 66. In this variation, volume can becalculated as the integral of the pressure increase over time.

FIG. 12 depicts a detailed view of the pressure measurement components62, 64 and 66 and orifice 68. Calculation of volume can be based uponthe Bernoulli Equation and Volume=Rate×Time. The discharge rate R iscalculated using the formula shown in FIG. 12 to the right where C_(s)is an empirically derived constant for calibrating the system, A2/A1 isthe ratio of the areas of orifice 68 (A2), first fluid channel 8 (A1)and “g” is the fluid density. The differential pressure 66 can be thepressure difference between inlet 62 (p1) and inlet 64 (p2). It can beassumed that density “g” of the fluid in medication container 20 is thatof water. However, other fluids with other densities can be used andcalculations adjusted accordingly. Volume calculation can be completedwithin circuit 60 before wireless transmission or circuit 44 (not shown)after wireless transmission.

In some variations, fluid delivery sensor 60 can be used to directlysense fluid flow. Such a fluid delivery sensor 60 can based upon one ofa paddle wheel flow meter, a turbine flow meter, a thermal flow meter,an ultrasonic flow meter, a coriolis type flow meter, etc.

FIGS. 13A and 13B depict differential pressure-time graphs at variouspoints in the operation of system shown in FIGS. 11A and 11B. FIG. 13Adepicts a normal pressure time graph. Initially at time t0, pressure isat level 70 with no force applied to the medication container 20. Attime t2 when the user increases force F by pressing on the plunger rodof a syringe or the medication container 20 of a reverse syringe,differential pressure increases from 70 to 72 at time t2 indicating useractivity. This higher pressure 72 is sustained over time from t2 to t6when the pressure returns to level 70 at time t7 when the medicationadministration is completed. The volume calculated confirms that themedication has been delivered. If the pressure is only maintained fromt2 to t3 then an incomplete volume has been delivered. Various timepoints t3, t4, t5 and t6 are indicative of 25%, 50%, 75% or 100% volumedelivered respectively. The volume calculation can be displayed to theuser providing feedback on volume delivered and time stamp logged as apartial dose of medication.

FIG. 13B depicts a different pressure-time graph where the pressure islower, indicative of slower delivery of medication. At time t1 theinitial pressure 70 increases to level 74 which is less than pressurelevel 72 in FIG. 13A. The pressure is maintained for a longer period oftime thru t3, t4, t5, and t6 where the pressure then decreases back tolevel 70 at time t7. Similarly as shown in FIG. 13A, if pressure is notsustained but instead drops down prematurely at t3, t4 or t5 anincomplete volume is calculated. There can be a number of othercombinations of times and differential pressures used in calculatingvolume.

FIGS. 14A and 14B depict two variations of data collection system 6.Display and recording system 48 can include any combination of hardwareand software to receive signals from transmitter 34 and records thesequence of medication administrations. Receiver 42 can be a receiveronly or a transceiver (i.e., a combined transmitter-receiver, etc.).

With reference to FIG. 14A, data collection system 6 can include ageneral purpose personal micro-computer 47 with a USB connection toreceiver 42. In another embodiment shown in FIG. 14B, data collectionsystem 6 can be stand alone and powered by a self-contained power source43. FIG. 14A depicts a general purpose USB device with receiver 42mounted in a USB housing with USB connection to a standardmicro-computer 47 and message decoder 46. Information 36 received byreceiver 42 is USB transferred to an external micro-computer 47.Software in message decoder 46 and micro-computer 47 can processinformation 36, add a time stamp from clock 49 and displays and logs theinformation via information display and recording system 48. Display,recording and logging function software is located in micro-computer 47.Micro-computer 47 can provide information 50 to a medical informationsystem 52 as shown in FIG. 5.

FIG. 14B depicts a more integrated, self-contained and dedicated datacollection system 6. Receiver 42, message decoder 46, micro-computer 47,display and recording system 48, clock 49 and micro-computer 47 arecombined into one module. Receiver circuit 42, message decoder 46 anddisplay and recording system 48 can be operated by micro-computer 47. Aself-contained power source 43 provides energy for mobile operation.

Information circuit 44 can include or otherwise use software to providethe data collection system functions. These functions can beconsolidated within a discrete data collection and record keeping deviceor distributed across a medical information system or a combination ofboth. When data collection system 6 is not functional or energized orwhen a patient is transferred from one data collection system 6 to asecond data collection 6 memory 38 provides a history of medicationadministration data as discussed above. In this case second datacollection system 6 can receive a medication administration data historyand timer counts between subsequent medication administrations. Thesoftware automatically associates the medication administrations withreal time from clock 49. Display recording system 48 is configured toprocess the previously recorded data, time stamp, log and display theinformation for the user.

Additionally, the software within data collection system 6 can includestored information in support of a series of medication administrationsbased upon an acute care protocol or various medication administrationsunrelated to an acute care protocol. Thus, the software can displaystored messages based upon medication injections in support of acutecare protocol providing health care providers guidance in the conduct ofthe protocol. The software within data collection system 6 can include aset of rules to cause alerts and or alarms to occur (directly by thedata collection system 6 or by transmitting data to another system,etc.) to inform the healthcare provider with information about theprotocol. The protocol can be a non-acute care protocol wherein the caremanagement of a patient is recorded and verified for proper drug, dose,time of administration. Other healthcare protocols can be envisionedthat require monitoring, verification and documentation of medicationadministration.

Care protocols, such as acute care protocols, can be updatedperiodically, annually, or when studies indicate a need for updating.Information circuit 44 can be configured to receive updated information50 from a medical information system 52 that is indicative of the mostrecent acute care protocols or protocol updates. Information circuit 44software is in turn configured to update itself pursuant to the updateinformation. The updated information can improve any operational aspectof the software.

While the discussion above describes an arrangement in which “raw” datais transmitted from the medication injection site 3 to the datacollection system 6 so that micro-computer 47 can process such raw datato identify traits such as patient identification (e.g., serial numberor other unique identifier of medication injection site 3), medicationcontainer contents, volume, expiration date, and/or pressure or volumeinformation, and/or other complementary information, it will beappreciated that one or more of such traits can be determined by themedication injection site 3. For example, memory 38 may contain mappingdata which associates raw data generated by identification sensor 18into one or more of: an identification of the patient or the medicationinjection site 3 (e.g., serial number, etc.), contents of medicationcontainer 20, volume of medication container 20, or expiration date ofthe contents of medication container 20. This information can then betransmitted by transmitter 34 to data collection system 6.

FIGS. 15A, 15 B and 15C depict housing 4 as shown in FIG. 3A separatedinto reusable sub-housing 80 and disposable sub-housing 82. FIG. 15Ddepicts housing 4 as shown in FIGS. 2C and 2D separated into reusablesub-housing 80 and disposable sub-housing 82. Various constructions canbe utilized that distribute elements of medication injection port 3either to reusable sub-housing 80 or to disposable sub-housing 82. Fourvariations are described below, however, other implementations can beadopted based on considerations such as overall size, weight,per-patient costs, etc. When used, reusable sub-housing 80 is connectedto disposable sub-housing 82 through interface 84. When connected,medication injection site 3 becomes functional by providing power frompower source 19 (“Batt”). When the power source is contained in reusablesub-housing 80 a charging element (not shown) can be configured torecharge the power source between uses. When the power source isself-contained within disposable housing 4 no recharging is needed (seeFIGS. 3A, 4A and 5).

FIG. 15A depicts a first sub-housing implementation in which reusablesub-housing 80 can include one or more of: transmitter 34, battery,indicator 35 and connector 86. In this variation, disposable sub-housing82 can include one or more of: memory 38, timer 39, sensor circuit 30,emitter/detector 31, flow sensor 60, identification sensor 18, firstfluid channel 8, second fluid channel 10, check valve 22, check valve 23and connector 88. Interface 84 can be formed by mating connector 86 withconnector 88 and can be one or more of an electrical contact, amechanical contact, an optical coupling, an electrical contact couplingor a magnetic coupling.

FIG. 15B depicts a second sub-housing implementation in which reusablesub-housing 80 can include one or more of: transmitter 34, battery,indicator 35, memory 38, timer 39 and connector 86. Disposablesub-housing 82 can include one or more of: sensor circuit 30,emitter/detector 31, flow sensor 60, identification sensor 18, firstfluid channel 8, second fluid channel 10, check valve 22, check valve 23and connector 88. Interface 84 can be formed by mating connector 86 withconnector 88 and can be one or more of an electrical contact, amechanical contact, an optical coupling, an electrical contact couplingor a magnetic coupling.

FIG. 15C depicts a third sub-housing implementation in which reusablesub-housing 80 can include one or more of: transmitter 34, battery,indicator 35, memory 38, timer 39, sensor circuit 30, emitter/detector31, flow sensor 60 and identification sensor 18. Disposable sub-housing82 can include one or more of: first fluid channel 8, second fluidchannel 10, check valve 22, and check valve 23. Interface 84 can beformed by one or more of a hydraulic coupling, a mechanical coupling, anoptical coupling, an electrical contact coupling or a magnetic coupling.

FIG. 15D depicts a fourth sub-housing implementation configured fordirect medication administration as shown in FIGS. 2C and 2D. Reusablesub-housing 80 is shown in the center and can include one or more of:transmitter 34, a processor, battery 19, indicator 35, memory 38, timer39, sensor circuit 30, emitter/detector 31, flow sensor 60 andidentification sensor 18. Disposable sub-housing 82 shown to the leftand to the right can include one or more of: second fluid channel 10 andcheck valve 23. The interface 84 between reusable sub-housing 80 anddisposable sub-housing 82 can be formed by one or more of a hydrauliccoupling, a mechanical coupling, an optical coupling, an electricalcontact coupling or a magnetic coupling.

FIGS. 16A, 16B and 16C depict three additional variations of datacollection system 6. FIG. 16A depicts a variation of a data collectionsystem in which data collection 6 is coupled to or forms part of asecondary medical device 100 such as an EKG monitor, an EEG monitor, ablood pressure monitor, a defibrillator, a pulse oximeter, an ETCO₂monitor, bar code medication administration (BCMA) system, an IV pump,or any other physical device and/or system used directly or indirectlyfor the delivery of patient care. Data collection system 6 can receivemedication administration data or other information 36 collected bymedication injection port 3 by receiver 42. Information 36 is processedthrough message decoder 46 to micro-computer 47. The softwareautomatically associates the time stamped medication administrations orother information received with real time using clock 49. Displayrecording system 48 can process the previously recorded data, timestamp, log and display the information for the user. The secondarymedical device 100 can provide information 50 such that it transfersmedication administration data or other information 36 from recordingsystem 48 to medical information system 52. Medical information system52 can be a single system or network of integrated systems including butnot limited to Admission, Discharge and Transfer Systems (ADT); PharmacyInformation Systems (PIS); OR Information Systems (ORIS); ElectronicMedical Record Systems (EMR); Patient Scheduling Systems (PSS);Electronic Medication Administration Systems (eMAR); and the like.Information 50 can also include data transmitted from medicalinformation system 52 to secondary medical device 100 applicable to theprocessing, routing and/or association of information 36 received frommedication injection port 3.

FIG. 16B depicts another variation of a data collection system 6 thatcan wirelessly receive information 102 from a secondary medical device100 such as an EKG monitor, an EEG monitor, a blood pressure monitor, adefibrillator, a pulse oximeter, an ETCO₂ monitor, a BCMA system, an IVpump, or other physical device and/or system used directly or indirectlyfor the delivery of patient care. In this configuration, transmitter 104within medical device 100 transmits information 102 to receiver 42within data collection system 6. Information 102 is processed throughmessage decoder 46 to micro-computer 47 and is time stamped by clock 49.This information is integrated in time with medication administration orother information 36 and is displayed and logged by recording system 48.The user can be provided with integrated data from medication injectionsite 3 and medical device 100.

FIG. 16C depicts another variation of a data collection system 6 thatcan wirelessly receive information 36 from medication site 3 and asecondary medical device 100 such as an EKG monitor, an EEG monitor, ablood pressure monitor, a defibrillator, a pulse oximeter, an ETCO₂monitor, a BCMA system, an IV pump, or other physical device and/orsystem used directly or indirectly for the delivery of patient care. Inthis configuration, transmitter 34 within medication site 3 transmitsmedication administration information 36 to receiver 42 within datacollection system 6. Data collection system 6 can be coupled to or formpart of a cellular phone 106. Additionally, data collection system 6within cellular phone 106 can wirelessly receive information 102 from asecondary medical device 100 such as an EKG monitor, an EEG monitor, ablood pressure monitor, a defibrillator, a pulse oximeter, an ETCO₂monitor, an IV pump, or other physical device and/or system useddirectly or indirectly for the delivery of patient care. Information 102is processed through message decoder 46 to micro-computer 47 and is timestamped by clock 49. This information 102 is integrated in time withmedication administration or other information 36 and is displayed andlogged by recording system 48. The user can be provided with integrateddata from medication injection site 3 and medical device 100. Thecellular phone 106 can provide information 108 such that it transfersmedication administration or other information 36 and medical deviceinformation 102 from recording system 48 to medical information system52. Information 108 can also include data transmitted from medicalinformation system 52 to cellular phone 106 applicable to theprocessing, routing and/or association of information 36 received frommedication injection port 3 and/or information 102 received from medicaldevice 100.

FIG. 17 depicts a second information source 224 and a secondidentification sensor 218. The second information source 224 can providecomplementary information associated with patient treatment, medicationinjections and/or use of medication port 3 on a particular patient or aspart of a particular clinical workflow activity. The second informationsource 224 can provide information relevant to patient treatment and/orclinician workflow that is otherwise independent from information readby information sensor 18. Identification sensor 218 can be used: 1.) inconjunction with identification sensor 18 to read data from informationsource 224 which is complimentary to information source 36; 2.)independent of identification sensor 18 to read data from informationsource 224 which is disparate from information source 24 but related tothe same patient and/or clinical workflow; or 3.) instead ofidentification sensor 18, in which case identification sensor 218functions as the primary identification sensor and information source224 serves as the primary information source.

The second identification source 224 can contain optical (1 dimensionalbarcode, 2 dimensional barcode, symbolic information, image or picture),magnetic (magnetic strip on an identification card/badge/ID tag), an NFCtag, biometric and/or RFID encoded or non-encoded information. Thesecond information source 224 can be illuminated by an optical emitter231 (LED). Information source 224 can take the form of a one dimensionalbarcode 224 a, a two dimensional barcode 224 b, a symbolic code 224 c(“IΔ‡KΩΔE”=ID Code) or other coded information. The information read bythe second identification sensor 218 can also take the form ofnon-encoded information such as a photograph, video, or biometriccharacteristic (fingerprint, heart rate, etc.). The information can beindicative of one or more of the following:

a patient, a patient demographic, a patient medical record (picture,video, biometric parameter patient ID, medical record number, weight,medical and/or medication history, present conditions, height, sex, age,eye color, allergies and/or other contraindications, Broselow color,etc.),

a patient sample (patient ID, blood sample, urine sample, tissue sample,stool sample, other body fluid sample, etc.),

a medical device (device ID, IV pump, EKG monitor, defibrillator, pulseoximeter, blood pressure monitor, etc.),

a patient input and/or output (medication, blood, urine, fluid, food,etc.),

a diagnostic test and/or treatment result (lab values, radiologicalimages and/or information, vital sign trends, EKG strip, clinicalreport, etc.),

a caregiver (picture, video, fingerprint, ID code/password, employee ID,name, affiliation, clinical role, responsibility for patient,decision-making authority etc),

a family member and/or companion (picture, video, fingerprint, IDnumber, affiliation, breast milk, organ donation, contact information,Advance Healthcare/Medical Directive authority and/or instructions,etc),

a pharmacy record (prescription number, patient ID, formulation,expiration date, administration instructions and/or precautions,contraindications, medication reconciliation information, pharmacy ID,preparer ID, etc.)

a physician's order (e.g., medication administration orders, lab orders,diagnostic testing orders, radiological orders, treatment and/or therapyorders etc.),

an environmental factor (room number, temperature, time, care transitionstatus, time of admission, time of last bed sheet change, etc).

In some variations, identification sensor 218 can generate suchinformation when second information source 224 is coupled or is inproximate location to second identification sensor 218. Identificationsensor 218 can be any one or more of: an optical sensor, a mechanicalsensor, an electrical sensor, a magnetic sensor, an NFC sensor, an RFIDsensor, a proximity sensor. A transmitter 34 can be disposed withinhousing 4 and in communication with or coupled to identification sensor218 to wirelessly transmit the information 236 generated by theidentification sensor 218 to the remote data collection system 6. Thesignal from identification sensor 218 can be processed and readied fortransmission by sensor circuit 30. Sensor circuit 30 processing caninclude but is not limited to decoding, encoding, pattern recognition(e.g. conversion of image date to text), filtering, image enhancement,analog to digital conversion, or mapping to secondary data via a lookuptable. A self-contained power source 19 (e.g., battery or battery array,etc.) can be disposed within housing 4 to provide power for one or moreof identification sensor 18, identification sensor 218, fluid deliverysensor 60, sensor circuit 30, transmitter 34 and indicator 35.

FIG. 18 depicts use of identification sensor 218 to detect informationfrom any applicable external information source 224. Information source224 can reside on or be integrated into medication containers 20(syringes, vials as shown) or other medication containers (fluid bags,ampoules, blood bags, IV tubing sets, medication patches, auto-injectiondevices, among others not shown). Information read by identificationsensor 218 from containers can include but is not limited to one or moreof: type of medication, concentration of medication, volume ofmedication, expiration date of medication, or the NDC or RXnorm code fora medication. An activation switch 232 can manually activate the emitter231 and information sensor 218 to detect information source 224.Identification sensor 218 can alternatively detect information from anon-medication information source 224 as depicted in FIG. 18. As shownin FIG. 18, information can include a patient wrist band 90, an oralsolid package 92, a patient sample container 94, and a medical device96. FIG. 18. provides illustrative examples of items which can be taggedwith information source 224 but is not meant to be limiting since theinformation read by identification sensor 218 can include or beindicative of any one of or a combination of the elements previouslydescribed. Information source 224 can be detected by information sensor218, transmitted to data collection system 6, processed there for timestamping, can be associated with patient identification or otherassociation factors, and further recorded in health system records.Processing of data received from information source 224 can be donecompletely by data collection system 6 or can be distributed across achain of devices and/or systems in communication with data collectionsystem 6 including medication injection site 3, medical device 100,cellular phone 106 and medical information system 52.

In one embodiment, for example, medication injection site 3 can serve asthe front end of a barcode medication administration system (BCMA),where identification sensor 218 can be a camera that can be used by aclinician to first read a patient ID encoded in information source 224on a patient wristband 90. The patient ID can be processed by datacollection system 6 using a data set of patient demographic datareceived from the ADT subsystem of medical information system 52. Theclinician can then use identification sensor 218 a second time to read amedication NDC number encoded in another information source 224 on amedication container 20 that can be a vial of medication. The NDC numbercan be processed by data collection system 6 to determine the medicationtype and concentration contained in the vial and can be verified againsta medication administration order received from the PIS subsystem ofmedical information system 52 to ensure the contents of the vial aresafe and appropriate for delivery to the patient whose patient ID waspreviously read. Once verified, the clinician can draw up the some orall of the contents of the vial into a syringe which can be fluidicallycoupled to medication port 13 and administered to the patient. Duringthe fluid administration, fluid flow characterization sensor 60 canmeasure the actual volume or composition of medication delivered to thepatient. Once fluid flow has stopped, data collection system 6, can usethe concentration read from the vial to convert the measured fluidvolume to dose administered; and that dose amount, the medication typeread, and any other pertinent data is aggregated, time stamped, and canbe sent by data collection system 106 to the eMAR subsystem of medicalinformation system 52.

Using similar logic and workflow, identification sensor 218 ofmedication injection port 3 can be utilized for other positive patientidentification (PPID) applications involving the collection, timestamping, association and recording of clinical items and/or activitiesrelated to a particular patient. Further examples of such PPIDembodiments include applications where clinical samples and/or specimensare matched to a patient; breast milk is matched to both a mother andchild; blood is matched to a patient; and medical devices are matched toa particular patient.

Identification sensor 218 can also be used for reading data intomedication injection port 3 for use at a future time. For example,identification sensor 218 can be used to read and store patientidentification and demographic information from information source 224such that each time a medication is administered through medicationinjection port 3, the stored patient data is referenced and used forrouting the resultant medication administration event data to the properpatient medical record. Similarly, identification sensor 218 can be usedto read and store patient-specific medication allergy information frominformation source 224 such that each time a medication container 20 iscoupled to injection site 13, the stored medication allergy informationis referenced and used to determine whether or not the patient has anallergy to the medication that is about to be administered. Suchprogramming and/or reference data can be used directly by medicationinjection port 3, or in combination with data collection system 106 andother devices and/or systems in direct or indirect communication withmedication injection port 3.

FIG. 19 is a diagram illustrating a fluid delivery tubing set 11connected to medication injection port 3 for continuous infusion to apatient. Tubing set 11 can be coupled to medication injection site 3input 13 and output 14 can be connected to downstream tubing leading toa patient. A patient access device 16 (catheter, needle) can couples thetubing set 11 to the patient. Housing 4 can contain a fluid flowcharacterization sensor 60 (a flow volume and/or flow rate measurement,a composition sensor (not shown), a pressure sensor (not shown), an airin line sensor (not shown), a temperature sensor (not shown)) or otherdetectors and/or sensors. In use medication port 3 can monitor and/ormeasure fluid delivery characteristics in tubing set 11. Initially, andupon fluid coupling of tubing set 11 to medication port 3, informationsource 24 on the luer output coupling fitting of tubing set 11 is readby information sensor 18. This fluid source information 24 can beassociated with a particular patient and/or procedure at the datacollection system 6. When fluid is administered to the patient, fluiddelivery sensor 60 can monitor and/or measure one or more of: fluidflow, fluid volume, fluid composition, air (absence of fluid),temperature, pressure. Additionally, data from the various sensors (flowvolume, flow rate, fluid composition, pressure, temperature, air, other)can be transmitted 36 to data collection system 6. Data collectionsystem 6 can provide various information 50 to medical informationsystem 52, a secondary medical device 100 (not shown), a cellular phone106 (not shown), a personal computing device (iPad or tablet computerfor example, not shown), a home health care transmitter or computingdevice (not shown).

Aspects of the subject matter described herein can be embodied insystems, apparatus, kits (e.g., kits with the medication injection sitebeing enclosed therein), methods, and/or articles depending on thedesired configuration. In particular, aspects of the subject matterdescribed herein can be realized in digital electronic circuitry,integrated circuitry, specially designed ASICs (application specificintegrated circuits), computer hardware, firmware, software, and/orcombinations thereof. These various implementations can includeimplementation in one or more computer programs that are executableand/or interpretable on a programmable system including at least oneprogrammable processor, which can be special or general purpose, coupledto receive data and instructions from, and to transmit data andinstructions to, a storage system, at least one input device, and atleast one output device.

These computer programs, which can also be referred to programs,software, software applications, applications, components, or code,include machine instructions for a programmable processor, and can beimplemented in a high-level procedural language, an object-orientedprogramming language, a functional programming language, a logicalprogramming language, and/or in assembly/machine language. As usedherein, the term “machine-readable medium” refers to any computerprogram product, apparatus and/or device, such as for example magneticdiscs, optical disks, memory, and Programmable Logic Devices (PLDs),used to provide machine instructions and/or data to a programmableprocessor, including a machine-readable medium that receives machineinstructions as a machine-readable signal. The term “machine-readablesignal” refers to any signal used to provide machine instructions and/ordata to a programmable processor. The machine-readable medium can storesuch machine instructions non-transitorily, such as for example as woulda non-transient solid state memory or a magnetic hard drive or anyequivalent storage medium. The machine-readable medium can alternativelyor additionally store such machine instructions in a transient manner,such as for example as would a processor cache or other random accessmemory associated with one or more physical processor cores.

To provide for interaction with a user, the subject matter describedherein can be implemented on a computer having a display device, such asfor example a cathode ray tube (CRT) or a liquid crystal display (LCD)monitor for displaying information to the user and a keyboard and apointing device, such as for example a mouse or a trackball, by whichthe user may provide input to the computer. Other kinds of devices canbe used to provide for interaction with a user as well. For example,feedback provided to the user can be any form of sensory feedback, suchas for example visual feedback, auditory feedback, or tactile feedback;and input from the user may be received in any form, including, but notlimited to, acoustic, speech, or tactile input. Other possible inputdevices include, but are not limited to, touch screens or othertouch-sensitive devices such as single or multi-point resistive orcapacitive trackpads, voice recognition hardware and software, opticalscanners, optical pointers, digital image capture devices and associatedinterpretation software, and the like.

The subject matter described herein may be implemented in a computingsystem that includes a back-end component (e.g., as a data server), orthat includes a middleware component (e.g., an application server), orthat includes a front-end component (e.g., a client computer having agraphical user interface or a Web browser through which a user mayinteract with an implementation of the subject matter described herein),or any combination of such back-end, middleware, or front-endcomponents. The components of the system may be interconnected by anyform or medium of digital data communication (e.g., a communicationnetwork). Examples of communication networks include a local areanetwork (“LAN”), a wide area network (“WAN”), and the Internet.

The computing system may include clients and servers. A client andserver are generally remote from each other and typically interactthrough a communication network. The relationship of client and serverarises by virtue of computer programs running on the respectivecomputers and having a client-server relationship to each other.

The subject matter described herein can be embodied in systems,apparatus, methods, and/or articles depending on the desiredconfiguration. The implementations set forth in the foregoingdescription do not represent all implementations consistent with thesubject matter described herein. Instead, they are merely some examplesconsistent with aspects related to the described subject matter.Although a few variations have been described in detail above, othermodifications or additions are possible. In particular, further featuresand/or variations can be provided in addition to those set forth herein.For example, the implementations described above can be directed tovarious combinations and subcombinations of the disclosed featuresand/or combinations and subcombinations of several further featuresdisclosed above. In addition, the logic flow(s) depicted in theaccompanying figures and/or described herein do not necessarily requirethe particular order shown, or sequential order, to achieve desirableresults. Other implementations may be within the scope of the followingclaims.

What is claimed is:
 1. A medication delivery apparatus for use with amedication source comprising: a housing; a fluid conduit at leastpartially extending within the housing and configured to delivermedication from the medication source to a patient via a parenteralfluid administration pathway; a medication port extending from anexternal surface of the housing and configured to be coupled to a tubingset coupled to the medication source, the medication port beingfluidically and directly coupled to the fluid conduit; and at least onefirst sensor disposed within the housing to generate informationcharacterizing administration of the medication for processing by aremote data collection system.
 2. A medication delivery apparatus as inclaim 1, further comprising: at least one second sensor disposed withinthe housing to generate complementary information for processing by theremote data collection system.
 3. A medication delivery apparatus as inclaim 2, wherein the complementary information comprises encodedinformation.
 4. A medication delivery apparatus as in claim 3, whereinthe remote data collection system associates the information generatedby the at least one sensor and/or the complementary informationgenerated by the at least one second sensor with one or more of:medication information, patient identification, patient weight, patientsex, patient age, patient BROSELOW color, pre-existing and/or currentpatient medical conditions, patient sample, medical device being used bythe patient, caregiver name, caregiver photograph, caregiver ID,caregiver employer, a pharmacy record, pharmacy administrationinstructions, physicians orders.
 5. A medication delivery apparatus asin claim 1, wherein tubing between the fluid conduit and a parenteralaccess device is 10 cm or less.
 6. A medication delivery apparatus as inclaim 1, further comprising: a transmitter within the housing totransmit information generated by the at least one sensor to the remotedata collection system; and a self-contained power source within thehousing powering the at least one first sensor and the transmitter.
 7. Amedication delivery apparatus as in claim 6, wherein the remote datacollection system receives information wirelessly from the transmitter.8. A medication delivery apparatus as in claim 1, wherein the housingcomprises a reusable sub-housing and a disposable sub-housing, thedisposable sub-housing being used by a single patient and including atleast the fluid conduit and the medication port, the reusablesub-housing being used by a plurality of patients and including the atleast one first sensor.
 9. A medication delivery apparatus as in claim8, wherein the re-usable sub-housing is operatively coupled to thedisposable sub-housing by a connection interface including one or moreof an electrical contact, an RF coupling, an optical coupling, ahydraulic coupling, a mechanical coupling, and a magnetic coupling. 10.A medication delivery apparatus as in claim 1, wherein the fluid conduitincludes a first fluid channel and a second fluid channel, the firstfluid channel extending from a first end to a second end, the secondfluid channel extending from a distal end and terminating at the firstfluid channel at an intersection intermediate the first end and thesecond end.
 11. A medication delivery apparatus as in claim 1, whereinthe medication delivery apparatus is integral to and/or configured to besuspended below a fluid source.
 12. A medication delivery apparatus asin claim 1, wherein the at least one first sensor includes anidentification sensor and the tubing set includes an information source,wherein the identification sensor reads the information from theinformation source.
 13. A medication delivery apparatus as in claim 12,wherein the information source is disposed proximate to a fitting of thetubing set.
 14. A medication delivery apparatus as in claim 13, whereinthe information source is disposed upon a cylindrical or annular surfacethat is concentric to the fluid outlet of the tubing set and the sensorgenerates the information characterizing administration of themedication when the tubing set is coupled and/or being coupled to themedication port.
 15. A medication delivery apparatus as in claim 1,wherein the at least one first sensor includes a fluid flow sensor andwherein the information includes information indicative of an amount offluid delivered from the medication source to the patient.
 16. Amedication delivery apparatus as in claim 1, wherein the at least onefirst sensor includes a medication composition type sensor, and whereinthe information includes information characterizing the composition ofthe medication.
 17. A medication delivery apparatus as in claim 1,wherein the remote data collection system receives, transmits,integrates and/or reports information from and/or to a medicalinformation source selected from a group comprising: a medical device,and a medical information system.
 18. A medication delivery apparatus asin claim 1, wherein the remote data collection system provides real-timeinformation to a user including medication information, medical dataspecific to a patient, procedural instructions and/or protocols forpatient treatment.
 19. A medication delivery apparatus as in claim 1,wherein the remote data collection system provides a rule set definingconditions to alert and/or guide a caregiver using the apparatus.
 20. Amedication delivery apparatus as in claim 1, further comprising: amemory element disposed within the housing for storing informationgenerated by the at least one first sensor.
 21. A medication deliveryapparatus as claim 1, further comprising: an indicator element disposedwithin the housing for indicating the operational state of themedication delivery apparatus and/or illuminating the medication portproviding user information.
 22. A medication delivery apparatus as inclaim 1, wherein the at least one first sensor is selected from a groupconsisting of: a flow volume sensor, a flow rate measurement sensor, acomposition sensor, a pressure sensor, an air in line sensor, and atemperature sensor.
 23. A kit comprising a sterile pouch enveloping amedication delivery apparatus as in claim 1, wherein the medicationdelivery apparatus is provided within the pouch in a sterile condition.24. A medication delivery apparatus for use with a medication sourcecomprising: a housing; a fluid conduit at least partially extendingwithin the housing and configured to deliver medication within themedication source to a patient; a medication port extending from anexternal surface of the housing and configured to be coupled to a fluidoutlet of a tubing set coupled to the medication source, the medicationport being fluidically and directly coupled to the fluid conduit; atleast one sensor disposed within the housing to generate informationcharacterizing administration of the medication; a transmitter withinthe housing to wirelessly transmit information generated by the sensorto a remote data collection system; and a self-contained power sourcewithin the housing powering the at least one sensor and the transmitter.25. A method for implementation by one or more data processorscomprising: receiving, by at least one data processor, information froma medication delivery apparatus characterizing administration ofmedication to a patient; associating, by at least one data processor,the information with data specifying at least one medication and/or avolume of medication; and promoting the associated data; wherein themedication delivery apparatus comprises: a housing; a fluid conduit atleast partially extending within the housing and configured to delivermedication from the medication source to a patient via a parenteralfluid administration pathway; a medication port extending from anexternal surface of the housing and configured to be coupled to a tubingset coupled to the medication source, the medication port beingfluidically and directly coupled to the fluid conduit; and at least onefirst sensor disposed within the housing to generate informationcharacterizing administration of the medication for processing by aremote data collection system.
 26. A method as in claim 25, whereinpromoting the associated data comprises: persisting the associated data,loading the associated data, presenting the associated data in a displaydevice, and/or transmitting the associated data to a remote computingsystem.